Footwear auxiliaries for synchronously toning leg muscles in order to straighten back posture

ABSTRACT

A programmable memory device for incorporation within a medium to distribute a force or shock, F, within the medium. It includes a programmable combination of micro-levers that cooperate in order to selectively disperse, absorb, redirect, reorient, or displace, at least part of the force, F, in a customizable fashion. At least one of the micro-levers includes a platform that is supported on a top portion of a support, in order to enable a lever action or momentum of the platform within the medium. As the force, F, is applied on the micro-lever, a reactive force, R, is generated and causes any a movement of the platform relative to the support or a movement of the support relative to the platform, effectively dispersing, absorbing, redirecting, reorienting, or displacing the force, F, within the medium.

PRIORITY AND RELATED APPLICATION

The present application is a continuation-in-part of co-pending U.S.patent application Ser. No. 13/889,316, filed on May 7, 2013, which isincorporated herein by this reference in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to footwear, and moreparticularly to footwear auxiliaries that synchronously tone the legmuscles in order to straighten the back posture.

BACKGROUND

Shoe insoles and various sole designs have been used to provide shockabsorbing features and thus reduce fatigue. With the miniaturization ofelectronic devices and the popularization of light emitting diodes(LEDs), shoe manufacturers have been trying to incorporate theseelectronics and LEDs in the shoe design for marketing purposes. Anexample of miniaturized electronics being incorporated within the shoedesign is described in U.S. patent application Ser. No. 15,288,472 filedon Oct. 7, 2016, and generally describes a sensor system fortransferring performance data.

However, the conventional footwear designs do not effectively target thetoning of the leg muscles in order to effect straightening of the backposture.

Sleep apnea is a breathing disorder characterized by brief disruptionsof breathing during sleep. When a person stops breathing during sleepdue to sleep apnea, the balance of oxygen and carbon dioxide in theblood is upset. This imbalance stimulates the brain to restart thebreathing process. The brain signals the person to wake up so that themuscles of the tongue and throat can increase the size of the airway, byallowing carbon dioxide to escape and oxygen to enter the airway. Thesewaking episodes are necessary to restart breathing, disrupt sleep, andmay cause daytime exhaustion.

There are two types of sleep apnea: central and obstructive. ObstructiveSleep Apnea (OSA) and Central Sleep Apnea (CSA). OSA is the most commontype of sleep apnea. It is caused by a breathing obstruction, whichstops the airflow in the nose and mouth. CSA is less common than OSA,and is manifested as a central nervous system disorder that occurs whenthe brain signal telling the body to breathe is delayed. CSA can becaused by disease or injury involving the brainstem, such as a stroke, abrain tumor, a viral brain infection, or a chronic respiratory disease.

While the causes of apnea are different in CSA and OSA, the symptoms andresults are generally similar, namely a deprivation of oxygen and poorsleep. The treatments for CSA include medications that stimulate theneed to breathe and administration of oxygen. As used herein, sleepapnea includes either CSA or OSA.

Normally, the muscles of the upper part of the throat keep the airwayopen to permit airflow into the lungs. When the muscles of the upperairway relax and sag, the relaxed tissues may vibrate as air flows pastthe tissues during breathing, resulting in snoring.

When a person has OSA, the throat collapses during sleep, blocking theairway and preventing air from getting to the lungs. Generally, thethroat muscles keep the throat and airway open. The resulting effect ofOSA could become serious.

Exemplary sleep apneas treatment devices are described in the followingpublications: U.S. Pat. Nos. 4,655,213; 5,176,618; 5,238,006; 5,466,193;7,353,826; 7,481,224; 7,487,777; 7,578,013; 7,578,294; 7,581,542; andD589140. Although several treatment devices have been described, themost common devices are classified into three categories: CPAP; dentalappliances, oral devices, and lower jaw adjustment devices; and surgery.

CPAP (Continuous Positive Airway Pressure) is widely recommended formoderate to severe obstructive sleep apnea. CPAP entails wearing amask-like device (or nose pillows) during sleep, in order to providecontinuous, positive, pressurized air to prevent the airway fromcollapsing. While CPAP has proven to be effective for numerous patients,many people find the apparatus uncomfortable and awkward to use,particularly due to air leaks at higher pressures. Some improvements tothe CPAP technology include options such as: “bilevel PAP,” whichswitches from higher to lower air pressure during the expiration; and“AutoPAP,” which uses an internal regulator that adjusts pressure ratherthan remaining at one fixed setting. Nonetheless, CPAP, as its nameindicates, still uses “continuous” positive pressure.

Dental appliances, oral devices, and lower jaw adjustment devices may bemade of acrylic and fit inside the mouth. Two oral devices that arecommonly used are the mandibular repositioning device and thetongue-retaining device. These oral devices open the airway by bringingthe lower jaw or tongue forward during sleep. While oral devices aremore convenient to use than CPAP, they are generally more effective formild to moderate sleep apnea cases. A number of side effects may resultfrom the use of the dental appliances, such as soreness, and damage to,or permanent change in position of the jaw, teeth, and mouth; salivabuild-up; and nausea.

Surgery can increase the size of the patient's airway. The surgeon mayremove tonsils, adenoids, or excess tissue at the back of the throat orinside the nose. The surgeon may reconstruct the jaw to enlarge theupper airway. Surgery may be an effective option for some patients;however, surgery carries the risks of surgical complications andinfections.

While the foregoing treatment devices are useful for their intendedpurposes, there remains an unsatisfied need for a simple, cost-effectivedevice, system, and method for reducing sleep disordered breathingevents.

In addition to the foregoing sleep disorder related concerns, anotherproblem arises for patients who use current respiratory devices, namelythe portability of the CPAP machines. A representative portable CPAPmachine is the Transcend CPAP, which is described at the following website: http://www.mytranscend.com/patients/why-transcend/, as having thefollowing dimensions: 6.1″×3.5″×2.8″. Although this device is relativelysmall, an extended use of this product may require an external battery,which adds to the size and weight of the CPAP machine. In addition, someof the limitations to the miniaturization of the Transcend CPAP may be:the continuous operation of the pump, the power supply, the pump design,and the electronic circuitry.

Therefore, there still remains an unsatisfied need for a simple,cost-effective portable breathing aid device, system, and method formore efficiently and economically providing added comfort to the users.

BRIEF SUMMARY

The present disclosure presents footwear designs and various auxiliariesthat effectively target the toning of the leg muscles in order tostraighten the back posture. To this end, a shoe sole is provided with aredress mechanism comprised of devices for redressing the positions ofthe shoe soles, in order to adjust the corresponding feet positions.

One of the main goals of the redress mechanism is to cause theconstituent devices to force the sole axes to rotate by appropriateangles, so that they become aligned with the respective redress axes. Inaddition, the redress devices will exert the necessary attraction forcesto maintain the shoe soles in the redress positions, for an extendedperiod of time in order to cause the complimentary skeletal muscles tobe toned and consequently assume the redress action on their own.According to another embodiment, the redress mechanism does not providethe attraction forces, but rather provides the user with a feedbacksignal or message when the shoe soles become misaligned (within acertain range) relative to the redress axes, to advise the user that anadjustment is needed.

According to the latter embodiment, the constituent devices of theredress mechanism include sensors that operate in conjunction with eachother to generate a feedback signal whenever the two soles are notwithin the parameters of a predetermined redress position. One or moreprocessors may be integrated as part of the constituent devices toevaluate the feedback signals generated by the sensors, and to forwardthe appropriate warning signal to a user feedback device, via one ormore transceiver.

In a more simplified design, only one processor and one transceiver maybe used. In an alternative embodiment, the processors are eliminatedaltogether, and the raw signals are transmitted directly to an externalfeedback device for processing and determination of the proximity of thetwo constituent devices relative to each other. These raw signals may betransmitted, wirelessly through one or more transceivers to either theuser through the external feedback device, or to one or more postureadjustment mechanisms that provide automatic redress.

A rechargeable power cell may be used within each constituent device topower the sensors, the transceivers, and the posture adjustmentmechanisms. A separate rechargeable power cell may be used to power thefeedback device. Some or all of the rechargeable power cells may be ofthe type described herein, using the body's own temperature heat, footpressure, or any other source described herein.

The present disclosure further describes shock absorbent “pebbles” thatcan be incorporated or formed within a medium or used separately,according to one embodiment of the present disclosure. An exemplarypebble is generally formed of an elastic membrane that deforms underpressure, and that defines two (or more) chambers that are connectedwith a gas permeable membrane. The membrane is permeable to air (or gas)but not to liquid. In a resting position, the first chamber is filledwith a mixture of gas along with liquid. The second chamber is filledwith the same (similar or dissimilar) gas as the gas. Both chambersremain at equilibrium until an external force is applied to the firstchamber and/or to the second chamber. In one embodiment, the fluid maybe agrose gel.

As an external force is applied to the first chamber, the fluidcontained therewithin may not be compressed, but the gas may becompressed. As a result, at least some of the gas molecules are forcedinto the second chamber, inflating it until such time as the externalforce is balanced by the gas pressure in the second chamber, at whichtime the flow of the gas molecules from the first chamber to the secondchamber stops. In consequence, the external force is absorbed by thepebble. The pebble may be micro-sized (as a micro-capsule) fordistribution over a large area, or sized according to the desiredapplication.

The present invention satisfies the foregoing need, and presents adevice, system, and method for reducing sleep disordered breathingevents (collectively referred to herein as “DPAP device”, “the presentDPAP device”, or “Discontinuous Positive Airway Pressure Device”).

The present DPAP device provides selective excitation to the pharyngealconduit or another muscle or cartilage along the respiratory path, apredetermined period of time before the end of the expiration stage, inorder to prematurely reverse the respiratory cycle before the totalcollapse of the pharyngeal conduit, thus enabling the inhalation stageto reopen and refill the pharyngeal conduit.

According to other embodiments of the present invention, the excitationsource includes a puff of positive air pressure, oxygen, another gas,electrical, and/or an audible (or sound) vibratory wave.

According to still other embodiments, the excitation source is appliedto pharyngeal conduit, the tongue, the palate, the epiglottis, salivaryglands, and/or other muscles or cartilages that can cause the prematurereversal of the respiratory cycle.

According to yet another embodiment, the DPAP device is a relativelysmall, portable, user-wearable, rechargeable, and cost-effectivebreathing aid (or assist) device that efficiently and economicallyprovides added comfort to the user. The DPAP device induces a prematureinhalations cycle, as needed, to avoid having the brain signal the userto wake up so that the muscles of the tongue and throat can increase thesize of the airway.

To this end, the DPAP device includes a sensor that identifies abreathing back pressure below a predetermined threshold, as theexhalation cycle approaches its virtual end.

The stimulation provided by the DPAP device can be either gradual (i.e.,soft) or stepped (i.e., hard). When using the gradual stimulation, ifafter a predetermined time period the induced (or natural) inhalationcycle does not start, then the DPAP device has the following twoalternative options:

-   -   The first option is for the DPAP device to continue the course        of the gradual stimulation until it reaches a sufficient        stimulation level.    -   The second option is for the DPAP device to apply a discrete        stimulation that induces the premature inhalation.

According to a preferred embodiment, the DPAP device uses a dentalappliance. The dental appliance may be made integrally with, and of thesame material as the oral tube. The dental appliance includes a formableor compliant section that fits over the user's teeth or gum, and aninternal extension. The dental appliance includes an opening thatenables the stimulation to be nozzled out of an outlet opening,directionally toward an intended target stimulation area.

According to a specific embodiment, the DPAP device establishes awireless (or remote) communication with an external communicationdevice, such as a smart phone and/or an external processor.

During regular breathing events, the teeth slightly pressed against thepliable section and deform it slightly so that it forms a resting seatfor the upper teeth. During regular breathing events, the pliablesection of the resting seat does not restrict the flow of fluid withinthe oral tube. The dental appliance maintains the upper and lower teethslightly separated.

The dental appliance includes a valve is normally closed as long as theuser does not grind the upper and lower teeth. The grinding motioncloses the pliable section of the resting seat, and a backpressure isbuilt within the dental appliance. This back pressure causes the valveto open and to direct the stimulation toward the teeth. Once thegrinding action stops, the flow through the nozzled opening resumes andthe valve is closed.

According to another embodiment, the DPAP device is used with a nasaltube. The nasal tube is typically looped around the user's ears anddelivers the stimulation to the nasal cavity. As the stimulation entersthe nasal cavity, it expands and vaporizes into particles that stimulatethe user's olfactory senses and cause a reaction of the uvula, thusclearing the airways for breathing.

According to another embodiment it would be possible to incite thedesired breathing response of a user, by stimulating various parts ofthe user's body, for example, the user's ear, the top of the head, orthe scalp. The stimulation can be done by means of one or a plurality ofholes, openings, or nozzles disposed along the nasal tube in order toallow at least some of the stimulation to escape and stimulate thetarget area.

According to another embodiment, one such opening is positioned in closeproximity to the user's ears to generate an auditory stimulation, suchas a high frequency pitch that causes the desired respiratory response.

Another DPAP device according to an alternative embodiment of thepresent invention, can be used as a retrofit to an existing CPAP device.The DPAP device makes use of the pumping force of the conventional CPAPdevice. The DPAP device includes a respiration sensor that can be wornby the user like a necklace due to its miniaturized size, as explainedearlier. The respiration sensor senses the onset of the exhalation stageand the approach of the stimulation point, E. To this end, the sensor isconnected to the nasal tube and is also connected to a valve via a fluidtube. The valve controls the flow of air from the CPAP device so thatthe DPAP device operates similarly to the DPAP device. The valve isconnected at its other end, to the hose. The valve can include a flowreducer that controls the rate of flow, the volume, and the pressure ofthe stimulation.

According to another design, the sensor is connected to the controlcircuitry of the CPAP device. Alternatively, the operation of the CPAPdevice can be reprogrammed to respond to the sensor and to operate theCPAP device according to the teachings of the present invention.

According to a specific embodiment, the DPAP device includes an infusionpump with one or more inlet port and one or more outlet port that permitthe exchange of fluid. The inlet port and the outlet port areconcentric. In one specific embodiment, the infusion pump is adual-spiral infusion pump

In the latter embodiment, the DPAP device includes a power cell thatcomprises a rechargeable battery charged by two or more chargingdevices, such as a Seebeck charger and a solar charger.

According to another embodiment, the DPAP device is used with a smartphone and/or an external processor. The DPAP device includes the powercell that supplies the necessary power to a stimulation source, arespiration sensor, and a transceiver. The power cell further includesan additional charging element, namely a piezoelectric vibration elementthat converts the vibrations of the DPAP device into electrical currentthat further charges the rechargeable battery. The vibration frequencyof the piezoelectric vibration element can be set to a predeterminedresonance frequency that maximizes the resonance, and thus maximizes theenergy conversion from vibration to electrical.

The power cell of the DPAP device may further include a heat absorbentsurface or heat sink that absorbs externally generated heat.

The power cell of the DPAP device may further be provided with aninductive element that inductively interacts with a similarly andgenerally oppositely situated inductive element, to provide vibration tothe piezoelectric vibration element, to heat the Seebeck charger, andwherein excess heat is absorbed by the heat absorbent surface, thusminimizing energy loss.

The DPAP device may be provided with a dual-spiral infusion pump.Alternatively, the DPAP device may be provided with an expansiondual-spiral pump.

According to another embodiment, the DPAP device may be provided with adual function infusion/expansion pump. In operation, during theinhalation stage, the pump intakes air and compresses it for exhaustthrough the nasal tube. During the expiration stage, the exhaled carbondioxide is pulled into the pump and expanded for exhaust.

According to still another embodiment, the DPAP device uses apressurized cartridge as a stimulation source.

BRIEF DESCRIPTION OF THE DRAWINGS

The various features of the present invention and the manner ofattaining them will be described in greater detail with reference to thefollowing description, claims, and drawings, wherein reference numeralsare reused, where appropriate, to indicate a correspondence between thereferenced items, and wherein:

FIG. 1 is a side, cross-sectional, elevational view of a person's headshowing a DPAP device according to the present invention;

FIG. 2 is a graph illustrating the respiratory cycle using the DPAPdevice of FIG. 1;

FIGS. 3 and 4 are flow charts illustrating the process of using the DPAPdevice of FIG. 1 for reducing sleep disordered breathing events, asshown in the chart of FIG. 2, wherein FIG. 3 illustrates the generalsteps of a method for initializing the DPAP device of FIGS. 1 and 2, andfurther wherein FIG. 4 illustrates the general steps of a method usingthe DPAP device of FIGS. 1 and 2;

FIG. 5 is a graph that illustrates a simplified respiratory cycle,similar to that shown in FIG. 2, showing an exemplary virtual behavior,at T₆, when the brain signals the person who does not use the DPAPdevice, to wake up so that the muscles of the tongue and throat canincrease the size of the airway;

FIG. 6 is another graph that illustrates a simplified respiratory cycle,similar to that of FIG. 5, showing a discrete or stepped stimulation atthe excitation point, E;

FIG. 7 is comprised of FIGS. 7A, 7B, and 7C, and illustrates threegraphs of a simplified respiratory cycle, similar to that of FIG. 5,showing a gradual stimulation during the shortened expiration stage;

FIG. 8 illustrates another DPAP embodiment according to the presentinvention, that can be worn by a user, as a necklace, and that uses adental appliance;

FIG. 9 is comprised of FIGS. 9A, 9B, and 9C, and illustrates the DPAPdevice of FIG. 8, in use with a variety of dental appliances;

FIG. 10 illustrates the DPAP device of FIG. 8, in use with a nasal tube;

FIG. 11 illustrates the DPAP device of FIG. 8, that can be worn by theuser, by means of a head gear;

FIG. 12 illustrates a plurality of DPAP devices of FIG. 8, that can beselectively worn by the user;

FIG. 13 illustrates another embodiment of the DPAP device according tothe present invention, that can be used as a retrofit to an existingCPAP device;

FIG. 14 is a block diagram of the DPAP device of FIG. 13, shown in useas a retrofit to the CPAP device;

FIG. 15A is a block diagram architecture of a DPAP device according to apreferred embodiment of the present invention, shown using a dual-spiralinfusion pump;

FIG. 15B is a top view of the DPAP device of FIG. 15A;

FIG. 16 is a block diagram of a power cell that forms part of the DPAPdevice of FIG. 15A;

FIG. 17 is another block diagram of the power cell of FIG. 16, showingthe layout of two different chargers and a rechargeable battery, whereinthe power cell can be used as an accessory to the DPAP device of thepresent invention, or it can be used independently with a variety ofother devices;

FIG. 18 is a high-level architecture of a DPAP device shown in use witha smart phone and/or an external processor, according to the presentinvention;

FIG. 19 is a more detailed architecture of the DPAP device of FIG. 14,illustrating two distinct power chargers;

FIG. 20 is a block diagram of the DPAP of the present invention, whichincludes another embodiment of the power cell, shown docked on anexternal charging station;

FIG. 21 is a bottom view of the power cell of the DPAP of FIG. 20;

FIG. 22 is a top view of the external charging station of FIG. 20;

FIG. 23 is a cross-sectional view of the dual-spiral infusion pump ofFIG. 15A, showing the air (or another gas) supply being pulled inbetween the two scrolls of the infusion pump;

FIG. 24 is a cross-sectional view of the dual-spiral infusion pump ofFIGS. 15 and 23, showing the air supply that has been previouslyintroduced in FIG. 23 being compressed, in preparation for release as astimulation (or excitation) at the excitation point, E;

FIG. 25 is a cross-sectional view of an expansion pump comprising aplurality of exhaust ports or valves that allow the expanding fluid tobe forced out of the expansion pump;

FIG. 26 is a cross-sectional view of a dual function infusion/expansionpump having basically the combined function of the dual-spiral infusionpump of FIGS. 23 and 24, and that of the expansion pump 2500 of FIG. 25,for use as a breathing assist device;

FIG. 27 is a block diagram of a DPAP device according to anotherembodiment of the present invention, shown using a pressurized cartridgeas a stimulation source;

FIG. 28 is a block diagram of an alternative DPAP device, similar tothat illustrated in FIG. 27, according to another embodiment of thepresent invention, shown using a pressurized cartridge as a stimulationsource, but without a processor or a power cell;

FIGS. 29, 30-, 31, 32, 33, 34, 35, 36 represent bottom views of shoesoles (or bottoms of the feet), that illustrated various resting feetpositions relative to each other;

FIG. 37 is a general illustration of the right leg muscles showingcomplementary muscles, such as the vastus leteralis and the vastusmedialis, that can be toned by the present invention;

FIGS. 38 and 39 represent the bottoms of the feet (or shoe soles) in twocommon resting positions, as shown in FIGS. 30 and 33 respectively, andin redress positions;

FIG. 40 represents the bottom view of the representative shoe soles ofFIG. 38, shown provided with a mechanism for redressing the positions ofthe shoe soles, in order to adjust the corresponding feet positions,according to one embodiment of the present disclosure;

FIG. 41 is a block diagram of the redress mechanism of FIG. 40,according to one embodiment of the present disclosure;

FIG. 42 is a flow chart illustrating a process for redressing thepositions of the shoe soles in order to adjust the corresponding feetpositions, according to one embodiment of the present disclosure;

FIG. 43 represents the bottom view of the representative shoe soles ofFIG. 40, shown provided with another mechanism for redressing thepositions of the shoe soles, in order to redress the corresponding feetpositions, according to one embodiment of the present disclosure;

FIG. 43A is a cross-sectional view of the right shoe sole of FIG. 43,taken along line A-A thereof, according to one embodiment of the presentdisclosure;

FIG. 44 is an elevational view of two shoes (footwear in dotted lines)illustrating yet another mechanism for redressing the positions of theshoe soles for adjusting the corresponding feet positions, according toone embodiment of the present disclosure;

FIGS. 45, 46, 47 data points representations of the mechanism forredressing the positions of the shoe soles for adjusting thecorresponding feet positions, according to one embodiment of the presentdisclosure;

FIG. 48 is a cross-sectional, fragmentary view of a shoe sole (orfabric) that incorporates micro-levers according to one embodiment ofthe present disclosure;

FIGS. 49, 50, 51 are top views of the sole (or fabric) of FIG. 48,showing the placements of various micro-levers (shown in dotted lines)within with sole, according to one embodiment of the present disclosure;

FIGS. 52, 53 are cross-sectional, fragmentary views of a shoe sole (orfabric) that incorporates micro-levers according to other embodiments ofthe present disclosure;

FIG. 54 is a cross-sectional, fragmentary view of a shoe sole (orfabric) that incorporates a dynamic micro-lever according to oneembodiment of the present disclosure;

FIG. 55 is a top view of the medium of FIG. 54, showing the placementsof various static and dynamic micro-levers (in dotted lines) within themedium, according to one embodiment of the present disclosure;

FIGS. 56, 57, 58, 59 illustrate various shock absorbent mechanisms thatcan be incorporated or formed within the sole of FIG. 55, according toone embodiment of the present disclosure; and

FIGS. 60, 61, 62, 63, 64, 65 illustrate alternative shock absorbent“pebbles” that can be incorporated or formed within the sole of FIG. 55,according to one embodiment of the present disclosure.

It should be understood that the sizes of the chart and the differentcomponents in the figures might not be in exact proportion, and areshown for visual clarity and for the purpose of explanation.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference is made herein to two related U.S. Pat. Nos. 5,578,077 and8,215,302, both of which are incorporated herein by this reference, intheir entirety.

FIG. 1 is a side view of a person's head 100 showing the placement of aDPAP device 10 according to the present invention. The person's upperairway 102 includes the pharynx 104 that splits into the larynx/trachea106 and the esophagus 108. Although the tissue along this airway isresponsive to the respiratory cycle, only the pharyngeal conduit 110,that includes the tissues in the region of the upper airway 102 thatstarts behind the nasal cavity 112 and ends in its connections to thelarynx 106, is totally collapsible.

The pharyngeal structure and individual anatomic components within theupper airway 102 include the pharyngeal walls; the base of the tongue114; the vallecula (or epiglottic vallecula); the hyoid bone 118 and itsattachments; the soft palate 119 with uvula 120, the palatine tonsilswith associated pillar tissue; and the epiglottis 122.

FIG. 2 is a chart that illustrates an exemplary respiratory cycle 200using the DPAP device 10 of FIG. 1 according to the present invention.This chart illustrates the variation (or dilation) of thecross-sectional area of the upper airway 102, with respect to thevarious phases of the respiratory cycle 200. At the initiation ofinspiration (Phase I), and as illustrated by the segment 202, which endsat T₁, the upper airway 102 begins to dilate. Thereafter, and asillustrated by the segment 204, that ends at T₂, the upper airway 102remains relatively constant through the remainder of inspiration (PhaseII).

At the onset of expiration (Phase III), and as illustrated by thesegment 206, that ends at T₃, the upper airway 102 begins to enlarge ordilate, reaching a maximum diameter at point 207. The upper airway 102then starts to diminish in size, as illustrated by the segment 208, sothat at the end of the natural expiration, without the correctiveexcitation of the present invention), it is at its narrowest,corresponding to the time T₄ when the upper airway (102) dilator musclesare least active, and positive intraluminal pressure is lowest.

The pharyngeal conduit 110 has the greatest potential for collapse andclosure at the end of the expiration stage (at time T₄). The dilatormuscle activation is directly related to airway narrowing and reducesresistance across patients with obstructive sleep apnea. R. Pierce, etal., “Upper Airway Collapsibility, Dilator Muscle Activation AndResistance In Sleep Apnoea,” European Respiratory Journal, Volume 30,Number 2, pages 345-353 (2007).

Sleep is characterized by a reduction in upper airway dilator muscleactivity. For the person with obstructive sleep apnea (OSA), it isbelieved that this change in muscle function causes pharyngeal narrowingand collapse. Current studies seem to support that OSA patients have anintrinsically structurally narrowed and more collapsible pharynx. IsonoS., et al., “Anatomy of Pharynx in Patients with Obstructive Sleep Apneaand in Normal Subjects,” J Appl. Physiol. 1997: 82:1319-1326.

Although anatomic closure is often accentuated at specific sites, suchas the velopharyngeal level, studies of closing pressures show that thenarrowing and collapse usually occurs along the entire length of thepharynx 104. Shellock F. G., et al., “Occlusion and Narrowing of thePharyngeal Airway in Obstructive Sleep Apnea: Evaluation by UltrafastSpoiled GRASS MR Imaging,” Am J of Roentgenology 1992:158:1019-1024.

The DPAP device 10 reduces sleep disordered breathing events byselectively providing excitation to the pharyngeal conduit 110 oranother muscle, cartilage, or element along the respiratory path of theupper airway 102 (collectively referred to herein as “selective elementsof the pharyngeal conduit”). This excitation is introduced at an optimalexcitation point, E, at time T₀, which is selected at a predetermined,but short, excitation period of time (or stimulation zone) E₀, beforethe virtual end, T₄, of the natural expiration stage. T₀-T₄ [T₄] is alsoreferred to herein as “the virtual period”.

The application of the excitation can also be quantified as a measure ofthe dilation of the pharyngeal conduit 110. In a preferred embodiment,the excitation (or stimulation) is applied as the dilation of thepharyngeal conduit 110 reaches approximately D₀. As a result, theexcitation point E could be determined as a function of two parameters,the dilation D₀ and the excitation period E₀: E(D₀, E₀).

These two parameters (D₀, E₀) vary for each individual, and are thuspersonalized. The selection of the excitation point E enables thepremature reversal of the respiratory cycle before the total collapse ofthe pharyngeal conduit 110, and shortens the natural occurrence of theexpiration or exhalation stage. As a result of such reversal, theinhalation stage is prematurely introduced, at about substantially theoptimal excitation period E₀ prior to its natural initiation. Thepremature initiation of the inhalation phase (Phase I) prematurelyreopens and commences the inflation of the pharyngeal conduit 110, priorto the expected total or substantial collapse of the pharyngeal conduit110. The premature inflation of the pharyngeal conduit 110 prevents theoccurrence of the apneic events.

More specifically, and still with reference to FIG. 2, the expirationstage is cut off at time T₀. Rather than allowing the pharyngeal conduit110 to follow its natural course and dilate, or more accurately deflate,following the path 212 (shown in dotted lines), the pharyngeal conduit110 is forced to be inflated along the path 210 (that ends at T₅).Consequently, according to the present invention, the expiration stage(phases III and IV) is shortened relative to the natural, uncorrected,expiration cycle, in order to provide the corrective treatment.

If the pharyngeal conduit 110 were allowed to collapse totally orsubstantially, then it would require air at higher pressure to cause itto open. However, if the pharyngeal conduit 110 were allowed topartially collapse, the pressure required to open it and to inflate itwould be significantly less than that required under the total collapse.As a result, the timing of the excitation according to the presentinvention is important to reduce the magnitude or amplitude of theexcitation.

To this end, the DPAP device 10 includes an excitation (or stimulation)source 124 that is connected to a respiration sensor (or monitor) 126via cables or fluid conduits 128 (that conduct a fluid or a gas). Therespiration sensor 126 is provided with electrodes 127 that collect thedesired respiration parameters, in order to allow the practitioner topersonalize the optimal excitation point E for each individual.

One (or two) nasal tube (mask or wire) 130 is connected to theexcitation source 124 at one end, with its other end partly inserted in(or covering) the nasal cavity 112. According to another preferredembodiment, an oral tube or an electrical wire 132, or a dentalappliance 150, is connected to the excitation source 124 at one end,with its other end partly inserted in (or covering) the mouth 134.According to still another embodiment, both the nasal tube 130 and oraltube 132 are connected to the excitation source 124, by means of a valve136.

Considering now the respiration sensor/monitor 126, its main functionsare: (1) upon initialization of the DPAP device 10 for the first time,the respiration sensor/monitor 126 assists the practitioner to determinethe optimal excitation point E for the particular use of the DPAP device10; and (2) for the normal use of the device, the respirationsensor/monitor 126 confirms the occurrence or presence of the excitationpoint E, and upon such confirmation it provides the necessary excitationto the user of the DPAP device 10.

The respiration sensor/monitor 126 uses the electrodes 127 to monitorthe respiratory cycle 200, and the progress of its four phases (I, II,III, IV), as is known or available in the field. As an example, therespiration sensor/monitor 126 monitors the variations in the relativeposition of the chest (as is currently done in a sleep study) in orderto calculate the occurrence of the parameters of the excitation point E:the dilation D₀ and the excitation period E₀: E(D₀, E₀).

According to another embodiment of the present invention, therespiration sensor/monitor 126 provides a feedback as to the efficacy ofthe excitation provided by the DPAP device 10 so as to vary the dilationD₀ and the excitation period E₀: E(D₀, E₀) of the excitation point E.

As an example, under certain conditions, such as when the individual oruser is sick and his/her respiration cycle does not follow the normalrespiratory cycle. As an illustration, if the respiration sensor/monitor126 determines the virtual time T₄, when the upper airway (102) dilatormuscles are expected to be least active, and the positive intraluminalpressure is the lowest (from previous measurements during respiratorycycles), and further determines that this virtual time T₄ is differentfrom the usual or normal virtual time T₄ that was determined at theinitialization stage, then the respiration sensor/monitor 126 couldautomatically adjust the dilation parameter D₀ of the pharyngeal conduit110 accordingly.

As another illustration, the respiration sensor/monitor 126 determinesvariations from the norm of the dilation parameter D₀ of the pharyngealconduit 110, then it could automatically adjust the virtual time T₄,could accordingly. In a preferred embodiment, the dilation D₀ exceedsapproximately 1 mm and the excitation period E₀ exceeds approximately 1millisecond.

Considering now the excitation source 124 could provide a variety ofexcitations, some of which are: a puff of positive air pressure, oxygen,another gas, electrical, and/or an audible (or sound) vibratory wave. Tothis end, in order for the excitation source 124 to provide a short puffof air or gas (i.e., oxygen or another gas), the excitation source 124includes a pump similar to that used in the CPAP device.

One distinction between the common CPAP device and the DPAP device 10 ofthe present invention is that in the present DPAP device 10 the puff ofpositive air is discontinuous, that is a puff of air is delivered at thedesired pressure but only for a very short period of time, such as 0.5second. Another desirable feature of the present DPAP device 10 is thatthe air puff pressure that this delivered intermittently (orperiodically) could be lower than the pressure at which air iscontinuously delivered by the CPAP device, in that the air puff isdelivered at the optimal excitation point E, prior to the collapse ofthe pharyngeal conduit 110.

According to another embodiment, in order for the excitation source 124to provide an electrical excitation, the excitation source 124 includesan electrical stimulation device, such as those used, for example, incardiac pacemakers or tachycardia devices.

According to still another embodiment, in order for the excitationsource 124 to provide an audible (or sound) vibratory wave, theexcitation source 124 includes a sound pressure pump capable ofgenerating vibratory waves, such as sound waves or other audible wavesthat are not limited to the audible frequency spectrum. The vibratoryfrequencies of the waves are selected to selectively cause selectedelements, muscles, ligaments, cartilage, or cavities to vibrate orresonate.

For example, the excitation source delivers a wave at, or about, theresonance or vibration frequency of the nasal cavity 112, at theexcitation point E. According to still other embodiments, the excitationsource 124 delivers a wave at, or about, the resonance or vibration ofthe pharyngeal conduit 110, the tongue 114, the palate 119, theepiglottis, the uvula 120, the salivary glands, the larynx/trachea 106,the esophagus 108, and/or other muscles or cartilages, including thehyoid bone 118, that can cause the premature reversal of the respiratorycycle 200, as described earlier.

In a specific preferred embodiment where the dental appliance 150 isused in conjunction with the oral tube 132 for delivering the puff ofgas, the dental appliance 150 may be made of the same material as theoral tube 132 for allowing the gas to pass therethrough. It includes aformable or compliant section 152 that fits over the user's teeth or gum160, and an internal extension 154. An oral extension extends from, andis in fluidic communication with the oral tube 132 via the compliantsection 152, into the user's mouth 134.

FIGS. 3 and 4 are flow charts illustrating the process of using the DPAPdevice 10 of FIG. 1 for reducing sleep disordered breathing events, asshown in the chart of FIG. 2. More specifically, FIG. 3 illustrates amethod 300 for initializing the DPAP device of FIGS. 1 and 2.

At step 302, method 300 measures the base excitation period E_(0B),pursuant to the chart of the respiratory cycle 200 of FIG. 2. At step304, method 300 measures the base virtual period T_(4B). Based on theseparameters of the base excitation period E_(0B) and the base virtualperiod T_(4B), method 300 determines the optimal excitation point E forthe particular user.

Considering now FIG. 4, it illustrates the general steps of a method 400using the DPAP device 10 of FIG. 1 that has been initialized accordingto method 300 of the present invention. At step 402, method 400 sets thebase excitation parameters (E_(0B), T_(4B)) of the excitation point Ethat were determined pursuant to method 300 of FIG. 3.

At step 404, the respiration sensor 126 (FIG. 1) monitors the approachof the excitation parameters (E₀, T₄) of the excitation point E to theirrespective base values (E_(0B), T_(4B)). At step 406, as soon as theexcitation parameters reach, or closely approach, their respective basevalues (E_(0B), T_(4B)), method 400 inquires if any of the excitationparameters (E₀, T₄) of the excitation point E has significantly changedrelative to its respective base value (E_(0B), T_(4B)), i.e., within anacceptable range, for instance 1% to 15%.

If method 400 determines that any of the excitation parameters (E₀, T₄)of the excitation point E has not significantly changed relative to itsrespective base values (E_(0B), T_(4B)), then method 400 proceeds tostep 408. At step 408, method 400 applies the excitation at theexcitation point E, in order to shorten the natural excitation stage.

If method 400 determines at step 406 that one or both of the excitationparameters (E₀, T₄) of the excitation point E has significantly changedrelative to its respective base values (E_(0B), T_(4B)), then method 400proceeds to step 410. At step 410, method 400 automatically adjusts theunchanged parameter and thus adjusts the occurrence of the excitationpoint E. Method 400 then proceeds to step 408 and applies the excitationat the excitation point E, in order to shorten the natural excitationstage.

It is to be understood that the specific embodiments of the inventionthat have been described are merely illustrative of certain applicationof the principle of the present invention. Numerous modifications may bemade to the description herein, without departing from the spirit andscope of the present invention. More specifically, while the presentembodiments of the invention refer to an exemplary medical oxygencylinder, it should be clear that the present respiratory gas deliverydevice may be used in conjunction (or be integrated) with other systems,such as: chemical oxygen generators, emergency oxygen systems providedfor example, on submarines and airplanes, self-contained breathingapparatus (SCBA), diving breathing systems, breathing masks forfirefighters, breathing masks during surgery, and in every situation orsystem that could benefit for the discontinuous gas delivery systemdescribed herein.

FIG. 5 is a graph 500 that illustrates a simplified respiratory cycle,similar to that shown in FIG. 2, where the inhalation graph portion 502replaces the graph sections 202, 204, and 206 (FIG. 2). Graph 500illustrates an exemplary behavior, at time T₆, following the end of theexpiration stage (at time T₄). At time T₆, the brain interprets therelatively flat line (shown in dotted line) of the graph 500, between T₄and T₆, as the patient's inability to breathe, and signals the patientto wake up, so that the muscles of the tongue and throat can increasethe size of the airway. The use of the DPAP device described hereinintroduces the stimulation, prior to time T₄ in order to induce apremature inhalation, thereby avoiding the brain induced event at T₆.

As stated earlier, the application of the excitation can be quantifiedas a measure of the dilation of the pharyngeal conduit 110. According toanother embodiment of the present invention, the stimulation is appliedwhen and if the sensor 126 identifies a breathing back pressure below apredetermined threshold, as the exhalation cycle approaches its virtualend at T₄.

According to still another embodiment of the present invention, thesensor 126 measures the rate of change of the exhalation graph, i.e.,the derivative relative to time or instantaneous slope, of theexhalation graph portion 505. If, at any time, during the stimulationperiod E₀ the absolute value of the rate of change of the exhalationgraph portion 505 is greater than a predetermined value for thisparticular patient, then a premature stimulation is introduced at E, inorder to induce a premature inhalation. As a result, stimulation isdelivery upon need, when necessary, in an attempt to anticipate and toprevent an apnea event.

FIG. 6 is another graph 600 that illustrates a simplified respiratorycycle, similar to that of FIG. 5, showing the stimulation at theexcitation point, E, or within the stimulation zone, E₀, as a discreteor stepped stimulation 610 that is preceded and succeeded by a lack ofstimulation 605, 615, respectively, in order to induce a prematureinhalation.

With reference to FIG. 7, FIG. 7A represents a graph 700 thatillustrates a simplified respiratory cycle, similar to that of FIG. 5,showing a gradual (or soft) stimulation 705 during an extendedstimulation period, E₁. The stimulation period, E₁, extends beyond thestimulation period E₀, so that the gradual stimulation 705 startsprematurely, at around time T₇, as shown, rather than around time T₀.

If after approximately a time period E₂, for example, at time T₈, eitherthe natural or the induced inhalation cycle does not start (or is notinduced), then the DPAP of the present invention has the following twoalternative options:

-   -   The first option is for the DPAP to continue, at time T₈, the        course of the gradual stimulation 705 until it reaches a        sufficient stimulation level at time T₀ that corresponds to        point E.    -   The second option is for the DPAP to apply, at a point F, that        corresponds to time T₈, a discrete (or hard) stimulation 710        (shown in dotted line) that induces the premature inhalation 210        at approximately point E and that terminates at time T₉.

It should be noted that time T₈ may, but not necessarily, correspond topoint F on the exhalation graph portion 505. In other terms, the gradualstimulation 705 in combination with the natural exhalation, are expectedto induce a predetermined pulmonary (or pharyngeal) dilation at time T₈.If the latter dilation is not naturally attained at time T₈, then thestimulation is applied. Otherwise, neither the gradual stimulation 705nor the discrete stimulation 710 is applied.

The advantage of this embodiment is that it minimizes the unnecessaryapplication of stimulations, such as when the gradual stimulation 705 incombination with the patient's natural expiration induce an inhalation,prior to a safety time zone E₄. The safety time zone E₄ is defined asthe difference between the extended stimulation period, E₁, and the sumof periods E₁ and E₂, as set forth in the following equation:E ₄ =E ₁−(E₂ +E ₃),Where E₃ represents the time period allocated to the application toeither the gradual stimulation 705 or the discrete stimulation 710.

According to still another embodiment of the present invention, the softstimulation or the hard stimulation following time T₈ are of differenttypes. As an exemplary illustration only, the soft stimulation 705 priorto point F may be air, but the soft or hard stimulation following pointF may be pure oxygen (or a different type of stimulation).

FIG. 7B illustrates another graph 725, wherein point F coincidesapproximately with point E, and the gradual stimulation 730 induces apremature inhalation, or the patient's natural inhalation is initiatedon its own, then the stimulation 730 will no longer be allowed tounnecessarily increase, and will thus be interrupted.

This embodiment addresses the fact that current CPAP devicesunnecessarily, continuously force air, and thus require continuous powereven if the patient's own inhalation cycle starts naturally. As a resultof the present reduction of power consumption during the inhalationstage and further during most of the exhalation stage, the powerrequirement to operate the present DPAP is significantly reduced, thusreducing the pump and battery sizes, rendering the DPAP amenable tobeing miniaturized, as it will be shown and explained herein.

FIG. 7C illustrates yet another graph 750, that is similar to FIG. 7A,wherein the gradual stimulation 705 induces a premature inhalation, orthe patient's natural inhalation 760 is initiated on its own, at oraround point F (time T₈). In which event, the stimulation 705 will nolonger be allowed to unnecessarily increase, and will thus beinterrupted. The dashed line 770 illustrates the virtual pulmonary (orpharyngeal) dilation, had the inhalation 760 not taken place.

The significant reduction in the power requirement to operate thepresent DPAP device, enables the miniaturization of the DPAP device tosuch a size that enables it to be wearable or portable by the user, andnot just simply transportable. One such DPAP 800 is illustrated in FIG.8 that shows the DPAP 800 being worn by a user as a necklace or pendant.

According to a preferred embodiment, the DPAP 800 uses a dentalappliance 810 that fluidly communicates with the DPAP 800 by means of anoral tube 820, which delivers the stimulation to the airways or morespecifically, as shown in this embodiment, to the user's front mouth,upper gum or teeth 825 (FIG. 8), lower gum or teeth 826 (FIG. 9), or theunderside of the tongue 114 (FIG. 9).

In a specific preferred embodiment where the dental appliance 810 isused in conjunction with the oral tube 820 for delivering the intakepuff of gas, the dental appliance 810 may be made integrally with, andof the same material as the oral tube 820 for allowing the gas to passtherethrough. The dental appliance 810 includes a formable or compliantsection 856 that fits over the user's teeth or gum 825, and an internalextension 858.

The dental appliance 810 includes an opening 888 that enables thestimulation, such as a gas puff, to be nozzled out of the dentalapplicant 810, directionally, toward the intended target stimulationarea. In FIG. 8, the opening 888 is positioned so that the stimulationis directed toward the upper teeth or gum 825.

In this particular embodiment, the DPAP 800 is shown in communicationwith an external communication device 890, such as a smart phone and/oran external processor over a wireless communication channel, such asBlue Tooth, Wi-Fi, or another available or known wireless protocol. Theexternal communication device 890 provides a variety of functions to theDPAP device 800, including but not limited to processing power forperforming calculations, thus reducing the components that would haveotherwise been added to the DPAP 800. This will reduce the powerconsumption of the DPAP 800 as well as its overall weight.

In FIG. 9A, the opening 999 is positioned so that the stimulation isdirected toward the lower teeth or gum 826 or the underside of thetongue 114. The dental appliance 910 is used in conjunction with theoral tube 820 for delivering the puff of gas (or stimulation). Similarto the dental appliance 810, the dental appliance 910 may be madeintegrally with, and of the same material as the oral tube 820 forallowing the gas to pass therethrough. The dental appliance 910 includesa formable or compliant section 956 that fits over the user's teeth orgum 826, and an internal extension 958.

The internal extension 958 includes an opening 999 that enables thestimulation to be nozzled out of the dental applicant 910,directionally, toward the intended target stimulation area, such as thelower teeth or gum 825 or the underside of the tongue 114.

According to yet another embodiment of the present invention, theinternal extension 958 or the compliant section 956 may include acombination of nozzles that are positioned to selectively direct anddistribute the stimulation to several target regions of the mouth.

As further illustrated in FIGS. 9B, 9C, the dental appliance 970presents an additional advantage to the user. The compliant section 971of the dental appliance 970 includes two additional features. The firstfeature is a soft or pliable section 958 that fits between the upper andlower teeth 825, 826. During regular breathing events, the teeth 925,926 slightly pressed against the pliable section 958 and deform itslightly so that it forms a resting seat for the teeth. During regularbreathing events, the pliable section of seat 958 does not restrict theflow of fluid within the oral tube 820.

The dental appliance 970 maintains the upper and lower teeth 925, 926,slightly separated. The variation of the thickness of the dentalappliance 970 may even provide some repositioning to the jaws to assistin maintaining the airway passages open.

The second feature of the dental appliance 970 is the valve 972 that ispreferably positioned on the tube 820 or the compliant section 970. Aslong as the user does not grind the upper and lower teeth 825, 826, thevalve 972 is normally closed, as shown in FIG. 9B.

However, with reference to FIG. 9C, since teeth grinding is believed tobe associated with sleep disorder, when the user starts to grind his/herteeth 925, 926, then the grinding motion closes the pliable section ofseat 958, and a backpressure is built within the tube 820. This backpressure (or another feedback) causes the valve 972 to open and todirect the stimulation toward the teeth 825 and/826, as explainedearlier. Once the grinding action stops, the flow through the nozzledopening 999 resumes and the valve 972 is closed.

It should be noted that the DPAP 800 can measure the back pressureresulting from the exhalation and from the closure of the pliablesection 958, to determine the onset of the exhalation, the stimulationpoint E, and the delivery and timing of the stimulation.

FIG. 10 illustrates the DPAP device 800 of FIG. 8, in use with a nasaltube 1000. The design and operation of the DPAP 800 enables its use witha simple nasal tube 1000 that is currently used in clinics andhospitals. Contrary to the conventional CPAP devices, the nasal tube1000 does not restrict natural breathing. In other terms, if the DPAP800 is turned off, the user will still be able to breathe. This is nottypically the case with conventional CPAP devices. As a result, the DPAP800 is a true assist device for breathing in that it selectivelysupplements natural breathing and does not regulate it completely.

The nasal tube 1000 is typically looped around the user's ears anddelivers the stimulation to the nasal cavity 112. As the stimulation,such as a puff of gas enters the nasal cavity 112, it expands and may,in certain events, vaporize into particles 1010. These particlesstimulate the user's olfactory senses and cause a reaction of the uvula120, thus clearing the airways for breathing.

FIG. 11 illustrates another way of donning the DPAP device 1100. TheDPAP 1100 can be worn by the user, by means of a head gear or a strap1101, and is connected to a nasal tube 1110, as explained earlier. TheDPAP device 1100 and the tube 1110 do not interfere with the user'ssleep positions, contrary to the conventional tubes that connect theconventional masks to the CPAP devices.

According to another embodiment of the present invention, it would bepossible to incite the desired breathing response of a user, bystimulating, for example, the user's ear, the top of the head, or thescalp. The stimulation can be done by means of one or a plurality ofholes, openings, or nozzles 1111, along the nasal tube 1110, in order toallow at least some of the stimulation to escape and stimulate thetarget area or areas.

According to another embodiment, one such opening 1155 is positioned inclose proximity to the user's ear or ears, to generate an auditorystimulation, such as a high frequency pitch that causes the desiredrespiratory response. It would also be possible to pre-train thepatient's automatic response to the auditory stimulation, to facilitatethe desired response.

FIG. 12 illustrates a plurality of DPAP devices of 800, 1100, 1200,1210, 1220, 1230, that can be selectively worn (one or more) by theuser, to effect the desired stimulation at different target areas orsites of the body. While only six exemplary DPAP devices are illustratedherein, it should be clear that a different number of DPAP devices aswell as their associated target stimulation areas may be selected tobest achieve the desired result. For illustration, the DPAP device 1230may be worn in proximity to the user's armpit (or another part of theuser's body) to provoke a change in the user's posture.

FIGS. 13 and 14 illustrate another DPAP device 1300 according to analternative embodiment of the present invention, which can be used as aretrofit to an existing CPAP device 1305. The operation of an exemplaryconventional CPAP device 1305 can be regulated by a softwareapplication, with the continuous air being forced out of a hose 1330that leads to a mask or some other respiration device.

The DPAP device 1300 makes use of the pumping force of the conventionalCPAP device 1305. The DPAP device 1300 includes a respiration sensor1310 that can be worn by the user like a necklace due to itsminiaturized size, as explained earlier. The respiration sensor 1300senses the onset of the exhalation stage and the approach of thestimulation point, E.

For example, the respiration sensor 1310 can measure the back pressureresulting from the user's exhalation (or the chest movement) todetermine the onset of the exhalation stage and to monitor theexhalation stage, in order to determine (or to have the CPAP softwaredetermine) or calculate the optimal stimulation point, E.

To this end, the sensor 1310 is connected to the nasal tube 1000 and isalso connected to a valve 1320 via a fluid tube 1340. The valve 1320controls the flow of air from the CPAP device 1305 so that the DPAPdevice 1300 operates similarly to the DPAP 800, as explained earlier.The valve 1320 is connected at its other end, to the hose 1330. Thevalve 1320 can include a flow reducer that controls the rate of flow,the volume, and the pressure of the stimulation.

According to another design, the sensor 1310 is connected to the controlcircuitry of the CPAP device 1305 by means of wiring 1345 (or wirelesslyby means of an interface). Alternatively, the operation of the CPAPdevice 1305 can be reprogrammed by the manufacturer (or a differentauthorized provider) to respond to the sensor 1310 and to operate theCPAP device 1305 according to the teachings of the present invention.

FIG. 15A is a block diagram architecture of a DPAP device 1500 (or ofthe DPAP device 800) according to a preferred embodiment of the presentinvention. The DPAP device 1500 generally includes a housing 1510 havinga top side(or top cover) 1515. As used herein, the directional terms“top,” “bottom,” or other similar terms, are not intended to limit theuse of the DPAP device e.g., 800, 1500 in a directional manner, but arerather used for illustration purposes, to facilitate the description ofthe present invention.

The DPAP device 1500 further includes an infusion pump 1555 with one ormore inlet port 1520 and one or more outlet port 1530, that permit theexchange of fluid through the top side 1515. It should however be clearthat while the inlet port 1520 and the outlet port 1530 are shown asbeing accessed from the top side 1515, other designs might be optimizedby accessing the inlet port 1520 and the outlet port 1530 from thelateral side 1517 (or another side) of the housing 1510.

As further illustrated in FIG. 15B, the inlet port 1520 and the outletport 1530 are concentric with a circular (or a different appropriateshape) cross-section. The inlet port 1520 may be covered by a filter1521 that filters the incoming air or gas. The outlet port 1530 isconnected to the nasal tube 1000.

In this particular embodiment, the infusion pump 1555 is the stimulationsource that generates the stimulation, such as an air (a fluid, gas, ora combination of a gas and liquid) puff. The inlet port 1520 allows air(or gas) to be introduced into the infusion pump 1555, while the outletport 1530 allows the pressurized air to be nozzled out of the infusionpump 1555 to provide the desired stimulation, as explained herein.

In one specific embodiment, the infusion pump 1555 is a dual-spiralinfusion pump, as described in more detail in U.S. Pat. No. 5,578,077 toKassatly. It should however be understood that different miniaturizedpump may alternatively be used. The infusion pump 1555 is housed insidethe housing 1510.

Another important feature of the DPAP device 1500 of the presentinvention, is the power cell 1600, which will be explained later in moredetail. The power cell 1600 is preferably self rechargeable, and powersthe various electrical and electronic components of the DPAP 1500, suchas the respiration sensor 1310, a micro-motor 1580, a controller 1590,and a processor 1595.

The micro-motor 1580 is coupled to the infusion pump 1555 and causes itsspiral-shaped scrolls to rotate. The controller 1590 regulates the flowof air and the delivery timing of the stimulation. The processor 1595performs the necessary computations and is programmable. It should beunderstood that, in order to reduce the power consumption of the DPAPdevice 1500, the processor 1595 could be done externally or remotely,such as by means of a smart phone/processor 890 (FIG. 8).

FIG. 16 is a block diagram of the power cell 1600 that forms part of theDPAP device 1500 of FIG. 15A, according to a preferred embodiment of thepresent invention. The power cell 1600 generally includes a rechargeablebattery 1616, of the type that is known or available. The rechargeablebattery 1616 is automatically charged by one or more charging devices.

In the exemplary embodiment of FIG. 16, the rechargeable battery 1616 isshown as being charged by two charging devices, a Seebeck charger 1661and a solar charger (or a light/photon charger) 1630. It should beunderstood that other chargers may alternatively be used, including butnot limited to an external charger that charges the rechargeable battery1616 directly.

In the embodiment illustrated in FIGS. 15A and 16, the micro-motor 1580is preferably a thermoelectric micro-motor that is powered by thethermoelectric effect. The thermoelectric effect is also referred to asthe Seebeck effect, and is used to generate electricity. Generally, thethermoelectric effect encompasses three separately identified effects:the Seebeck effect, the Peltier effect, and the Thomson effect.

In general, a thermoelectric device includes one or a series of p-typesemiconductor elements and one or a series of n-type semiconductorelements that are electrically connected. When the two dissimilarelements are subjected to different temperatures, the Seebeck effectcauses a voltage to be generated across the junctions between the p-typeand n-type semiconductor elements.

The solar charger 1630 can further heat the Seebeck elements of theSeebeck charger 1661, to generate additional temperature differentialthat causes the Seebeck charger 1661 to generate electricity forcharging the rechargeable battery 1616.

FIG. 15B shows the DPAP device 1500 as having a cylindrical shape with acircular top side 1515. This exemplary top side 1515 accommodates theinlet port 1520 and the outlet port 1530. The inlet port 1520 and theoutlet port 1530 are concentric, but they can assume other positions andshapes. As illustrated in FIG. 15A, the outlet port 1530 is connected tothe nasal tube 1000, while the inlet tube can preferably be capped witha filter 1521 that captures undesirable particles.

FIG. 17 is another block diagram of the power cell 1600 of FIG. 16,showing the layout of two different chargers 1620, 1630 and therechargeable battery 1616. The power cell 1600 can be used as anaccessory to the DPAP device 1500 of the present invention, or it can beused independently with a variety of other devices.

In this specific exemplary embodiment, the rechargeable battery 1616 ofthe power cell 1600 is placed centrally, and is electrically connectedto the Seebeck charger 1620 by electrical contacts 1710, 1720. Therechargeable battery 1616 is also electrically connected to the solarcharger 1630 by means of electrical contacts 1730, 1740. Additionalelectrical contacts, connect the rechargeable battery 1616 to othercomponents of the DPAP device 1500, including but not limited to thecontroller 1590, the micro-motor 1580, and the processor 1595.

The power cell 1600 may be used independently of the DPAP devices of thepresent invention, and due to its miniaturized size and effectiveness,it can be used to power various electrical and electronic devices. As anexample, the power cell 1600 can be miniaturized to power nano devices,whether or not they are implantable or introducible inside the body.

FIG. 18 illustrates a DPAP device 1800 in use with a smart phone and/oran external processor 890. To this end, the DPAP device 1800 includesthe power supply 1616 that supplies the necessary power to a stimulationsource 1820, a respiration sensor 1310, and a transceiver 1805.

As further illustrated in FIG. 19, the transceiver 1805 includes atransmitter 1902 and a receiver 1925. FIG. 19 further illustrates thestimulation source 1820 as including, for illustration purpose only, theSeebeck charger 1620 and the solar charger 1630.

In use, the DPAP device 1800 is worn by the user as a necklace, with theSeebeck charger 1620 in contact with the user's skin, whether with orwithout a electrolytic gel. The user's body temperature will raise andsustain the temperature of the Seebeck charger 1620 for generatingcharging power to the rechargeable battery 1616. The solar charger 1630further supplements the charging of the rechargeable battery 1616.

When the DPAP device 1800 is not in use, it can be placed on a separate,external charging dock or station 2002, as it will now be described inconnection with the DPAP device 2000 of FIG. 20.

FIG. 20 illustrates the DPAP device 2000 docked on the external chargingstation 2002. The external charging station 2002 may also be used withthe DPAP device 1800 of FIGS. 18 and 19 and the other DPAP devices ofthe present invention.

The DPAP device 2000 is generally similar in function and design to theDPAP device 1800, but it further includes an additional chargingelement, namely the piezoelectric vibration element 2010. Thepiezoelectric vibration element 2010 converts the vibrations of the DPAPdevice 2000 into electrical current that further charges therechargeable battery 1616. The vibration frequency of the piezoelectricvibration element 2010 can be set to a predetermined resonance frequencythat maximizes the resonance, and thus maximizes the energy conversionfrom vibration to electrical (or vice versa as needed). As an example,the piezoelectric vibration element 2010 can be tuned to resonate at theuser's heart rate, and therefore the piezoelectric vibration element2010 becomes sensitive to, and captures the heart vibrations. In oneembodiment, the piezoelectric vibration element 2010 can generateseveral milliwatts of power.

The DPAP device 2000 further includes a heat absorbent surface or heatsink 2012 that absorbs the heat from a heat source 2030 of the heatsource 2002.

The DPAP device 2000 may further be provided with an inductive element2020, that extends circumferentially, within and along the periphery ofthe DPAP device 2000. The inductive element 2020 inductively interactswith a similarly and generally oppositely situated inductive element2035, to provide vibration to the piezoelectric vibration element 2010,heat to the Seebeck charger 1620, and wherein excess heat is absorbed bythe heat absorbent surface 2012, thus minimizing energy loss.

In use, the DPAP device 2000 is placed atop the docking station 2002,such that the heat source 2030 faces the heat absorbent surface 2012,and the inductive element 2035 faces the inductive element 2020 of theDPAP device 2000. The docking station 2002 is generally cylindricallyshaped with horizontal dimensions that substantially match those of theDPAP device 2000.

The piezoelectric vibration element 2010, the Seebeck element 1620, theheat absorbent surface 2012, the inductive element 202, and in certaindesigns, the solar charger 1630, are collectively referred to as powercell 2050.

FIG. 21 is a bottom view of the power cell 2050 of the DPAP 2000 of FIG.20. FIG. 22 is a top view of the external charging station 2002 of FIG.20.

FIG. 23 is a cross-sectional view of an exemplary stimulation device ofFIG. 15A, which comprises a dual-spiral infusion pump 1555. The infusionpump 1555 intakes air (or another gas) supply through an intake port orvalve 2310, inside a body 2305, through two scrolls 2320, 2330. Asstated earlier, the operation of the dual-spiral infusion pump 2300 incompressing or expanding a fluid 2340 is explained in more detail inU.S. Pat. No. 5,578,077 to Kassatly, which is incorporated herein byreference in its entirety.

FIG. 24 is another cross-sectional view of the dual-spiral infusion pump1555 of FIG. 23, showing the air supply that has been previouslyintroduced in FIG. 23 being compressed, in preparation for release as astimulation (or excitation) at the excitation point, E, through anoutput port 2323. As shown in FIG. 15A, the output port 2323 isconnected through port 1530, to the nasal tube 820.

FIG. 25 is a cross-sectional view of an expansion pump 2500, havingbasically the same or similar components as those of the dual-spiralinfusion pump 1555 of FIGS. 23 and 24, and further comprising aplurality of exhaust ports or valves 2350, 2351, 2352, 2353, 2354, 2355that are distributed at predetermined locations so as to allow theexpanding fluid 2340 to be forced out of the expansion pump 2500.

To this end, the fluid 2340 is inputted through the port 2323, and therelative motion of the scrolls 2320, 2330 is the reverse of that of thecorresponding scrolls 2320, 2330 of the spiral infusion pump 1555 ofFIGS. 23 and 24. Alternatively, the exhaust ports 2350, 2351, 2352,2353, 2354, 2355 are omitted and the fluid 2340 is allowed to exhaustthrough the port or valve 2310. While only six exhaust ports 2350, 2351,2352, 2353, 2354, 2355 are illustrated, it should be clear that adifferent number of exhaust ports may be selected.

In one embodiment, the positioning of the exhaust ports 2350, 2351,2352, 2353, 2354, 2355 is such that they are located at the maximaldistance between the two scrolls 2320, 2330, as shown by the doublearrow “AB” relative to the exhaust port 2351.

FIG. 26 is a cross-sectional view of a dual function infusion/expansionpump 2600, having basically the combined function of the dual-spiralinfusion pump 1555 of FIGS. 23 and 24, and the expansion pump 2500 ofFIG. 25, for use as a breathing assist device, including its use as aCPAP device, a DPAP device, a breathing apparatus for diving.

In operation, during the inhalation stage 502 of the respiratory cycleof FIG. 5, the pump 2600 intakes air, oxygen, or another breathing gas2340 through the port 2310 and compresses the gas 2340 for exhaustthrough the port 2323, as explained earlier. During the inhalation stage502, the exhaust ports 2350, 2351, 2352, 2353, 2354, 2355 are closed toprevent the escape of the gas and to ensure increase pressure.

During the expiration stage 505, the exhaled carbon dioxide is pulledinto the pump 2600 through the port 2323, and expanded to exhaustthrough the exhaust ports 2350, 2351, 2352, 2353, 2354, 2355, with theport 2310 being closed, to ensure that the carbon dioxide is notbreathed in by the user.

FIG. 27 represents a DPAP device 2700 according to another embodiment ofthe present invention, shown using a pressurized cartridge 2727 as astimulation source. In this embodiment, the DPAP device 2700 uses thepressurized cartridge as its stimulation source, thus simplifying itsoperation and reducing its cost.

The DPAP device 2700 uses the processor 1595 to regulate the opening andclosing of an outlet valve 2730, to deliver the stimulation, asdescribed herein, via the nasal tube 1000. The pressurized cartridge2727 can be filled with either air or another appropriate breathing gas,under pressure.

Since the use of the pressurized cartridge 2727 is limited during sleep,the size of the pressurized cartridge 2727 can be miniaturized. Thepressurized cartridge 2727 can be replaced, as needed, by sliding it inand out of the body 1510 through an opening 2750.

FIG. 28 is a block diagram of an alternative DPAP device 2800 that isgenerally similar to the DPAP device 2700 of FIG. 27, according toanother embodiment of the present invention, shown using a pressurizedcartridge 2727 as a stimulation source, but without the processor orpower cell of the DPAP device 2700. According to this embodiment, theoutlet valve 2730 is regulated to open and close and thus torespectively release or block the flow of the gas or air, by, forexample, the respiration sensor 126.

FIGS. 29 through 36 represent bottom views of shoe soles (or bottoms ofthe feet), that illustrated various resting feet positions relative toeach other. FIG. 29 shows shoe soles 2900 positioned in a resting (i.e.,non-moving) standing position, which represents an ideal position (alsoreferred herein to as target or redress position), in which the soles(or feet) 2900 are aligned with two parallel, longitudinal axes 2902,2904 (also referred to herein as target or redress axes).

FIG. 30 shows shoe soles 3000 positioned in a resting (i.e., non-moving)standing position, which represents an undesirable position thatrequires redress according to one or more embodiments of the presentdisclosure. In this position, both longitudinal axes 3002, 3004 of thesoles (or feet) 3000 diverge from the redress axes 2902, 2904 of FIG.29.

FIG. 31 shows shoe soles 3100 positioned in a resting (i.e., non-moving)standing position, which represents an undesirable position thatrequires redress according to one or more embodiments of the presentdisclosure. In this position, one of the longitudinal axes 3102, 3104 ofthe soles (or feet) 3100 diverges from the redress axes 2902, 2904 ofFIG. 29.

Similarly, FIG. 32 shows shoe soles 3200 positioned in a resting (i.e.,non-moving) standing position, which represents an undesirable positionthat requires redress according to one or more embodiments of thepresent disclosure. In this position, one of the longitudinal axes 3202,3204 of the soles (or feet) 3200 diverges from the redress axes 2902,2904 of FIG. 29.

FIG. 33 shows shoe soles 3300 positioned in a resting (i.e., non-moving)standing position, which represents an undesirable position thatrequires redress according to one or more embodiments of the presentdisclosure. In this position, both longitudinal axes 3302, 3304 of thesoles (or feet) 3300 converge relative to the redress axes 2902, 2904 ofFIG. 29.

FIG. 34 shows shoe soles 3400 positioned in a resting (i.e., non-moving)standing position, which represents an undesirable position thatrequires redress according to one or more embodiments of the presentdisclosure. In this position, one of the longitudinal axes 3402, 3404 ofthe soles (or feet) 3400 converges relative to the redress axes 2902,2904 of FIG. 29.

Similarly, FIG. 35 shows shoe soles 3500 positioned in a resting (i.e.,non-moving) standing position, which represents an undesirable positionthat requires redress according to one or more embodiments of thepresent disclosure. In this position, one of the longitudinal axes 3502,3504 of the soles (or feet) 3500 converges relative to the redress axes2902, 2904 of FIG. 29.

FIG. 36 shows shoe soles 3600 positioned in a resting (i.e., non-moving)standing position, which represents an undesirable position thatrequires redress according to one or more embodiments of the presentdisclosure. In this position, both longitudinal axes 3602, 3604 of thesoles (or feet) 3600 deviate from the redress axes 2902, 2904 of FIG.29.

While FIGS. 29 through 36 illustrate various resting feet positions, itshould be understood that moving (i.e., running or walking) might carryover (i.e., translate) these positions and possibly exacerbate thedisparity in the leg muscle development. FIG. 37 provides a general,visual illustration of such exemplary leg muscles that might be affectedby unbalanced development.

As background information, the thigh has three sets of strong muscles:the hamstring muscles in the back of the thigh, the quadriceps musclesin the front, and the adductor muscles on the inside. The quadricepsmuscles and hamstring muscles work together to straighten (extend) andbend (flex) the leg. The adductor muscles pull the legs together. Theskeletal muscles are generally grouped together in pairs on theskeleton, and they interact and work together in opposition.

Skeletal muscles only pull in one direction. For this reason, theyalways come in pairs, wherefore these pairs of muscles will be referredto herein as “complementary muscles.” When one muscle in a paircontracts, to bend a joint for example, its counterpart then contractsand pulls in the opposite direction to straighten the joint out again.Without this arrangement, a person would not be able to straighten thelegs when walking or bending the fingers to grip something. As anexample, when the biceps muscle in the upper arm contracts, it pulls thelower arm in towards the shoulder. However, when it relaxes, the bicepscannot push the arm back out. To do this, the triceps muscle, on theunderside of the upper arm contracts and straightens the arm out. If thetriceps muscle were not there, the arm would stay drawn in permanently.

Similarly, the skeletal muscles of the legs work in opposition. As anexample, the vastus lateralis 3700, which is also called the “vastusexternus” is the largest and most powerful part of the quadricepsfemoris. It arises from a series of flat, broad tendons attached to thefemur, and attaches to the outer border of the patella. It ultimatelyjoins with the other muscles that make up the quadriceps in thequadriceps tendon, which travels over the knee to connect to the tibia.

The muscle that interact with the vastus lateralis 3700 is the vastusmedialis 3737, which is also called the vastus internus is an extensormuscle located medially in the thigh that extends the knee. The vastusmedialis 3737 is part of the quadriceps muscle group.

There exists a direct relationship between the two vastus lateralis 3700and the two vastus medialis 3737 of both legs on one end, and thepositioning of the feet on the other end. More specifically, If thevastus lateralis 3700 of one leg were more developed than the vastusmedialis 3737, then the vastus lateralis 3700 will pull the associatedfoot outward. Similarly, if the vastus medialis 3737 of the leg weremore developed than the vastus lateralis 3700, then the vastus medialis3737 prevails, and will pull the associated foot inward.

More specifically, FIG. 29 shows shoe soles (or feet) 2900 positioned inan ideal position, indicating that the vastus lateralis 3700 and thevastus medialis 3737 are properly and symmetrically “toned” in that theytend to exert the appropriate balanced pull forces on the feet 2900, tokeep them aligned with the longitudinal axes 2902, 2904.

On the other hand, FIG. 30 shows shoe soles (or feet) 3000 that arepositioned in an undesirable position which requires redress accordingto one or more embodiments of the present disclosure. In this position,the vastus lateralis muscles 3700 of both legs is more developed thanthe corresponding vastus medialis muscles 3737, and thus thesecomplementary muscles tend to exert asynchronous, unbalanced pull forceson the feet 3000, causing the latter to diverge outwardly from theredress axes 2902, 2904 of FIG. 29.

FIG. 31 shows shoe soles (or feet) 3100 that are positioned in anundesirable position which requires redress according to one or moreembodiments of the present disclosure. In this position, the vastuslateralis muscles 3700 of the left leg (with a corresponding axis 3104)is more developed than the corresponding vastus medialis muscles 3737,and thus these complementary muscles tend to exert asynchronous,unbalanced pull forces on the feet 3100, causing the left foot todiverge outwardly from the redress axis 2904 of FIG. 29.

FIG. 32 shows shoe soles (or feet) 3200 that are positioned in anundesirable position which requires redress according to one or moreembodiments of the present disclosure. In this position, the vastuslateralis muscles 3700 of the right leg (with a corresponding axis 3102)is more developed than the corresponding vastus medialis muscles 3737,and thus these complementary muscles tend to exert asynchronous,unbalanced pull forces on the feet 3200, causing the right foot todiverge outwardly from the redress axis 2902 of FIG. 29.

FIGS. 33 through 36 illustrate variations of feet positions as describedabove in connection with FIGS. 29 through 32.

FIG. 38 illustrates the soles (also referred to herein as “sole pair”)3000 that include a right sole 3010 and a left sole 3020. In thisexample, the axis 3002 of the right sole 3010 deviates by an angle α ofapproximately +17° from the corresponding redress axis 2902. Similarly,the axis 3004 of the left sole 3020 deviates by an angle β ofapproximately −24° from the corresponding redress axis 2904. In otherterms, both feet or soles 3010, 3020 need to be rotated in oppositedirections toward the redress positions shown in FIG. 29, so that theaxis 3002 corresponds with the redress axis 2902, and the axis 3004corresponds with the redress axis 2904. In addition, the redresspositions need to be maintained so that the vastus lateralis muscles3700 and the vastus medialis muscles 3737 of both legs be trained andremain synchronously toned.

The center of rotation CR of the right sole (or foot) 3010 is definedherein as the intersection of the axis 3002 and the redress axis 2902.Similarly, the center of rotation LR of the left sole (or foot) 3020 isdefined herein as the intersection of the axis 3004 and the redress axis2904. It should be noted that while the center of rotation CR fallswithin the footprint of the sole 3010, the center of rotation LR fallsoutside the footprint of the sole 3021 and is thus referred to herein asa virtual center of rotation. It should also be noted in this examplethat the angles of rotations a and β do not necessarily need to be equaland that each foot needs to be redressed differently.

FIG. 39 illustrates the soles (also referred to herein as “sole pair”)3300 that include a right sole 3310 and a left sole 3320. In thisexample, the axis 3302 of the right sole 3310 deviates by an angle a ofapproximately −17° from the corresponding redress axis 2902. Similarly,the axis 3304 of the left sole 3320 deviates by an angle β ofapproximately +24° from the corresponding redress axis 2904. In otherterms, both feet or soles 3310, 3320 need to be rotated in oppositedirections toward the redress positions shown in FIG. 29, so that theaxis 3302 corresponds with the redress axis 2902, and the axis 3304corresponds with the redress axis 2904. In addition, the redresspositions need to be maintained so that the vastus lateralis muscles3700 and the vastus medialis muscles 3737 of both legs be trained andremain synchronously toned.

This example illustrates the fact that the center of rotations CR and CLdo not necessarily have to lie along axis 3333, which is perpendicularto the redress axes 2902, 2904.

Referring now to FIGS. 40, 41, 42, and starting with FIG. 40, itrepresents the bottom view of the representative shoe soles 3010, 3020of FIG. 38, shown provided with a redress mechanism 4000 comprised ofdevices (or elements) 4010, 4020 for redressing the positions of theshoe soles 3010, 3020, respectively, in order to adjust thecorresponding feet positions, according to one embodiment of the presentdisclosure.

FIG. 41 is a block diagram of the redress mechanism 4000 of FIG. 40,according to one embodiment of the present disclosure. FIG. 42 is a flowchart illustrating a process 4200 for redressing the positions of theshoe soles 3010, 3020 in order to adjust the corresponding feetpositions, according to one embodiment of the present disclosure.

The redress mechanism 4000 aims at redressing the shoe soles 3010, 3020along the respective redress axes 2902, 2904, and further at maintainingsuch redress over an extended period of time (e.g., ranging from minutesto hours), in order to cause the complimentary skeletal muscles to betoned and consequently assume the redress action (or process) on theirown. To this end, the redress mechanism 4000 is comprised of devices (orelements) 4010, 4020 (FIGS. 40, 41) that are respectively secured to theshoe sole 3010, 3020.

While the present disclosure describes one embodiment of the presentinvention as securing the redress mechanism 4000 to the shoe soles 3010,3020, it should be clear that the redress mechanism 4000 mayalternatively be incorporated within insoles (also represented by thenumeral references 3010, 3020) that can be inserted inside the shoesoles. Alternatively, the redress mechanism 4000 may be attached thelower legs, above the shoes. It should also be clear that while thepresent invention is described herein in connection with leg muscles andfootwear, it is not limited to this particular application. Rather, thepresent invention may be used with other complementary muscles of thebody for numerous purposes, including, without limitation: physicaltherapy, and exercises.

With reference to FIG. 40, one of the main goals of the redressmechanism 4000 is to cause the constituent elements 4010, 4020 to forcethe sole axes 3002, 3004 to rotate by appropriate angles, so that theybecome aligned with the respective redress axes 2902, 2904. In addition,the redress elements 4010, 4020 will exert the necessary attractionforces F1, F2, to maintain the shoe soles 3010, 3020 in the redressposition, for an extended period of time. According to anotherembodiment, the redress mechanism does not provide the attractionforces, but rather provides the user with a feedback signal or messagewhen the shoe soles 3010, 3020 become misaligned (within a certainrange) relative to the redress axes 2902, 2904, to advise the user thatan adjustment is needed.

According to the latter embodiment, and with reference to FIG. 41, theelements 4010 and 4020 of the redress mechanism 4000 include sensors4150, 4180, respectively. These sensors 4150, 4180 work in conjunctionwith each other to generate a feedback signal whenever the two soles3010, 3020 are not within the parameters of a predetermined redressposition. Although the ideal redress position may be illustrated in FIG.29, it should be understood that for certain users, such as patients,such ideal redress position might not be the desired position, and assuch, acceptable parameters or ranges of positions may be set orindividualized for each user.

One or more processors, such as the processors 4152 and 4182, may beintegrated as part of the elements 4010 and 4020 to evaluate thefeedback signals generated by the sensors 4150, 4180, and to forward theappropriate warning signal to a user feedback device 4190, via one ormore transceiver 4154, 4184. In a more simplified design, only oneprocessor and one transceiver may be used. In an alternative embodiment,the processors 4152, 4182 are eliminated altogether, and the raw signalsare transmitted directly to the external feedback device 4180 forprocessing and determination of the proximity of the two elements 4010,4020 relative to each other. These raw signals may be transmitted,wirelessly through one or more transceivers 4154, 4184 to either theuser through the external feedback device 4180, or to one or moreposture adjustment mechanisms 4158, 4188 that provide automatic redress,as it will be explained later in more detail.

The sensors 4150, 4180 may include a photo-light sensor or a proximitysensor that measures the proximity of the two elements 4010, 4020, andthus the two shoe soles 3010, 3020, relative to each other.

A rechargeable power cell 4156, 4186 may be used within each element4010, 4020, to power the sensors 4150, 4180, the transceivers 4154,4184, and the posture adjustment mechanisms 4158, 4188. A separaterechargeable power cell may be used to power the feedback device 4180.Some or all of the rechargeable power cells may be of the type describedherein, using the body's own temperature heat, foot pressure, or anyother source described herein.

With reference to steps 4205 and 4210, the redress process 4200 isinitiated by measuring and setting the initial settings for each foot orsole of the user, in a rest standing position. To this end, and withfurther reference to FIG. 41, the axes 3002 and 2902 (described earlier)of the right sole 3010 are drawn or measured in order to determine thecenter of rotation CR, the angle of rotation a (which in this example isa=+17°, and the center reference point, K, which is the midpoint betweenthe two redress axes 2902, 2904 along axis 4050 that virtually connectsthe elements 4010, 4020 and that is perpendicular (or normal) to theredress axes 2902, 2904.

Similarly, and with respect to the left sole 3020, the axes 3002 and2902 (described earlier) are drawn or measured in order to determine thecenter of rotation CL, and the angle of rotation β (which in thisexample is β=−24°. The weight, height, and pace size of the user arealso measured, as well as the location of pressure (or contact) pointsof the soles with ground as the soles land on the ground while the useris walking (running, or performing another activity).

As shown in FIG. 40, the elements 4010, 4020 may, for example only, bedisposed near the tip of the soles 3010, 3020, along the axes 3002,3004, although other locations may alternatively be appropriate. At step4210 of the process 4200 the distance, D, between the two elements 4010,4020 in the resting position is measured or determined. Similarly, thedistance, d, between the two elements 4010, 4020 in the redress positionis also measured or determined.

At step 4220 of the process 4200, the user is requested to take onestride forward, as is shown in FIG. 44, and the distance between the twoelements 4010, 4020 is measured. In FIG. 44, the two elements aredesignated by the references S2, S5, and the distance therebetween isdesignated by S25, which is measured or calculated.

Using the foregoing data points, the processors 4152, 4182 and/or theexternal feedback device 4180 estimates (or approximates) the forces F1,F2 that need to be exerted on each sole 3010, 3020, independently, tocause redress. It should be noted that the forces F1, F2 do notnecessarily need to be equal, and that these forces F1, F2, whether theyare attraction or repulsion forces, are calculated individually for eachfoot or sole.

At step 4225, and as explained earlier, during use, the feedback device4180 advises or reminds the user to adjust for non-desirable variances,optionally aided by the posture adjustment mechanism 4158, 4188.

According to one embodiment of the present invention, the postureadjustment mechanism 4158, 4188 may include two electro-magnets that arepolarized so that they are attracted to (or alternatively, for theposition shown in FIG. 39, repulsed from) each other, thus forcing oneor both soles or feet to also be rotated toward the desired redressposition. It should be understood that while the present invention isdescribed in more detail with regard to the generation of attractionforces F1, F2, it should be clear that repulsive forces may be generatedusing a similar concept.

FIG. 43 represents the bottom view of the representative shoe soles3010, 3020 of FIG. 40, shown provided with the first redress mechanism4000 and further provided with a second redress mechanism 4300 forredressing the positions of the shoe soles, in order to redress thecorresponding feet positions, according to one embodiment of the presentdisclosure.

In this illustration, and as described earlier, the first redressmechanism 4000 includes two elements 4010, 4020. These elements 4010,4020 may be sensors and/or electro-magnets; however, for the sake ofthis example, the two elements 4010, 4020, will be assumed to be sensorsS2, S5, respectively, and that the second redress mechanism 4300includes the two electro-magnets M1, M2.

The second redress mechanism 4300 will now be described in more detail.The second redress mechanism 4300 generally includes two pulley-drivenmechanisms 4310, 4320, one for each sole 3010, 3020, respectively. Thesepulley-driven mechanisms 4310, 4320 can for example, be encapsulatedwithin the shoe soles 3010, 3020. Starting with the right sole mechanism4310, it generally includes a magnet M1 or a solenoid (FIGS. 56-59),such as an electro-magnet that generates a force F1. In this example,the force F1 is an attraction force. However, it should be clearlyunderstood that the present invention is not limited to attractionforces, but the magnet M1 may be so polarized as to exert either anattraction or a repulsion force.

The right sole redress mechanism 4310 further includes a pulleymechanism 4311 that is secured to the magnet M1 (or the plunger of thesolenoid). The pulley mechanism 4311 includes a pulley setup 4312 thatamplifies the attraction force F1 by a factor “p” so that the effectivepull or attraction force becomes pF1. The pulley mechanism 4311 furtherincludes an additional pulley (or another mechanism) 4314 that changesthe direction of the force to provide a lever effect.

To this end, the pulley mechanism 4311 further includes a cable 4315that is secured to the magnet M1 and to the pulley setup 4312, and thatfurther wraps around the pulley 4314, to be connected to the center ofrotation CR that acts as an anchor. As a result, the right sole redressmechanism 4310 effectively exerts the force pF1 around the center ofrotation CR.

In this illustration, the number of force amplifying pulleys is shown tobe two; however, a different number of force amplifying pulleys may beselected dependent on the desired angle of rotation a and theamplification factor “p.” In one embodiment, the angle of rotation a isset to be equal to the angle formed between axes 4016 and 4017. Axis4016 may be the extension of the cable 4315, while axis 4017 may beformed by the center of rotation CR and the center of the first pulley,nearest the magnet M1.

FIG. 43A is a cross-sectional view of the right shoe sole 3010 of FIG.43, taken along line A-A thereof, according to one embodiment of thepresent disclosure. FIG. 43A illustrates one exemplary way ofencapsulating the right sole redress mechanism 4310 with the sole 3010.The right sole 3010 can be molded or manufactured integrally toincorporate the redress mechanism 4310.

Alternatively, the shoe sole 3010 can be formed of a bottom part 4350that is molded to form the lower half of a spacing of chamber 4343 thathouses the redress mechanism 4310 when the shoe sole 3010 is assembled.The individualized redress mechanism 4310 is then assembled within thechamber 4343. An upper part 4354 of the shoe sole 3010 is then formedand secured to the bottom part 4350 along the surface represented by adashed line 4352. It should be noted that the chamber 4343 enables thepulley assembly to function freely therewithin, without obstruction.

A plug 4360 made of a suitable material may be formed to complete theencapsulation of the pulley assembly 4310 within the sole 3010. The plug4360 may be made, for example, of a plastic material. Alternatively, theplug 4360 may be made of a material that is conductive to generatedelectro-magnetic field of the magnet M1. In the latter example, it wouldbe desirable to include another plug on the opposite side to that of theplug 4360. The pulley assembly 4320 of the left sole 3020 may be madesimilarly to the assembly method described herein in connection withFIG. 43A.

Returning now to pully driven mechanism 4320 of FIG. 43, it generallyincludes a magnet M2 or a solenoid (FIGS. 56-59) that is generallysimilar to the magnet M1, for generating a force F2. In this example,the force F2 is an attraction force. However, it should be clearlyunderstood that the present invention is not limited to attractionforces, but the magnet M2 may be so polarized as to exert either anattraction or a repulsion force.

The left sole redress mechanism 4320 further includes a pulley mechanism4321 that is secured to the magnet M2 (or the plunger of the solenoid).The pulley mechanism 4321 includes a pulley setup 4322 that amplifiesthe attraction force F2 by an amplification factor “q” so that theeffective pull or attraction force becomes qF2. The pulley mechanism4311 further includes an additional pulley (or another mechanism) 4324that changes the direction of the force to provide a lever effect.

To this end, the pulley mechanism 4321 further includes a cable 4325that is secured to the magnet M2 and to the pulley setup 4322, and thatfurther wraps around the pulley 4324, to be connected to a substitutecenter of rotation “An” that acts as an anchor. The reason for theselection of the substitute center of rotation “An” is that in thisillustration, the actual center of rotation CL is virtual and thus thesubstitute center of rotation “An” is selected on the rearward orrearwardmost part of the sole 3020, in proximity (or in closestproximity) to the center of rotation CL. As a result, the left soleredress mechanism 4320 effectively exerts the force qF2 around thesubstitute center of rotation “An.”

In this illustration, the number of force amplifying pulleys is shown tobe three; however, a different number of force amplifying pulleys may beselected dependent on the desired angle of rotation β and theamplification factor “q.” In one embodiment, the angle of rotation β isset to be equal to the angle formed between axes 4026 and 4027. Axis4026 may be the extension of the cable 4325, while axis 4027 may beformed by the substitute center of rotation “An” and the center of thefirst pulley, nearest the magnet M2.

It should be noted that the amplification factors “p” and “q” are notnecessarily equal, depending on the required attraction force by eachsole 3010, 3020. In this illustration, the redress angle of rotation β(which in this example is β=−24° is greater than the redress angle ofrotation a (which in this example is a=+17°, and thus requires a greaterattraction or redress force qF2. As a result, the pulley mechanism 4321is illustrated to include three pulleys, while the pulley mechanism 4312is shown to include two pulleys. Alternatively, the two redress pulleyassemblies 4311 and 4321 may be identical but the magnets M1, M2 may beselected to generate the required attraction forces F1, F2.

FIG. 44 is an elevational view of two shoes (footwear in dotted lines),a right shoe 4410 and a left shoe 4420, and illustrates anothermechanism 4400 for redressing the positions of the shoe soles in orderto adjust the corresponding feet positions, according to one embodimentof the present disclosure. In addition to what has already beendescribed earlier in connection with shoe soles, FIG. 44 illustrates amore elaborate data collection schemes of three-dimensionally positionedredress devices S1, S2, S3, S4, S5, S6 that acts as data points, asfurther illustrated in FIGS. 45, 46, 47.

In these drawings, the designation “Dxy” refers to the distance betweenthe redress devices Sx and Sy. For instance, D25 refers to the distancebetween the redress devices S2 and S5. To be noted that the redressdevices S3 and S6 are secured to the upper part of the heels (along theZ-axis) so as to provide more accurate three-dimensional readings andredress adjustments. In FIGS. 44, 46, 47 the user is making a stridefrom the initial resting position of FIG. 45.

FIG. 48 is a cross-sectional, fragmentary view of a shoe sole 4800(fabric or any other suitable environment such as packaging, mattresses,etc.) that incorporates a plurality of micro-levers 4810, 4820,according to one embodiment of the present disclosure. In this example,the micro-levers 4810, 4820 are encapsulated within a synthetic resin oranother suitable plastic, pliable material 4830 that is preferably butnot necessarily formed on a base 4840 that may be formed for example, ofrubber or hard plastic to provide solid support for the micro-levers4810, 4820.

Considering now the micro-lever 4810, it is formed of a material that isstiffer or harder than the pliable material 4830, so that when a forceis applied on the micro-lever 4810, it is capable of bending or plyingin the direction of the applied force. Although two exemplary designsfor the micro-levers 4810, 4820 are described herein, it should beunderstood that the inventive concept is applicable to differentlyshaped micro-levers.

The micro-lever 4810 is formed of two parts: an upper, balanced platform4811; and a bottom support 4812. The upper platform 4811 is supported,in this example, on the apex of the bottom support, in order to form alever, so that when force F is applied onto one end of the upperplatform 4811, a reactive force R is generated on the other end of theupper platform 4811.

As a result, the micro-levers 4810, 4820 can be encapsulated within thesole or insole of a shoe to provide support and comfort. In thisexample, the micro-lever 4810 does not allow the force F to reach theground, but rather selectively disperses, absorbs, redirects (i.e.,changes the direction of) the force F, into the reactive force R thatlifts the user's sole, thus aiding the user by providing added comfortduring use.

A heat source 4850 may optionally be secured to the micro-lever 4810,heat it, so as to make the surrounding pliable material 4830 morecompliant so as to allow the micro-lever 4810 to ply more easily. Tothis end, the micro-lever 4810 may be made of a metallic material thatis conductive to heat. Although the heat source 4850 is shown as anexternal source, it should be clear that the heat source 4850 can beencapsulated within the base 4840, fed by friction, electricity, or anyother suitable or known heat source that can be fitted within the base4840.

The micro-lever 4810 is referred to herein as “micro” because of itsability to be miniaturized for use in compact places and for thedissemination of distribution over a large surface area. It shouldhowever be understood that the general concept of the present inventionmay be used in other applications, regardless of the size of the leverformed according to the teaching of the present invention. Suchapplications are anticipated and covered by the present disclosure.

The micro-lever 4820 is generally similar in design and function to themicro-lever 4810, with the exception that the micro-lever 4820 has aunitary construction so that the apex of the bottom support 4822 (havinga generally triangular cross-section) is fused within the upper platform4821.

FIGS. 49, 50, 51 are top views of the sole (or fabric) 4800 of FIG. 48,showing the placements of various micro-levers 4810, 4820, 5000, 5100,5110, 5120, 5130, 5140 (in dotted lines) within with the sole, accordingto one embodiment of the present disclosure. With reference to FIG. 49,the upper platforms 4811, 4821 of the micro-levers 4810, 4820 are shownto be circularly shaped. It should be understood that the shape of theupper platforms is not determinative or limiting to the general conceptof the present invention, and that the embodiments shown in FIGS. 48through 51 are for illustration purpose only.

FIG. 50 illustrates the rectangular (or square) shape of the upperplatform of a micro-lever 5000. FIG. 51 illustrates other micro-levers5100, 5110, 5120, 5130, 5140 having various shapes for the upperplatform. For example, the upper platform of micro-lever 5100 iscomprised of two superposed platforms that are disposed at right anglerelative to each other. The upper platforms of micro-levers 5110, 5111are generally similar to the upper platform of micro-lever 5100 with theexception that the superposed platforms form different angles relativeto each other. The upper platform of micro-lever 5130 has threesuperposed platforms, while the upper platform of micro-lever has twosuperposed platforms of different shapes (circular and rectangular). Theshapes and the superposition of the platforms depends on the desiredredistribution of the reactive forces, in order to effect apredetermined result or application.

FIGS. 52, 53, 54 are cross-sectional, fragmentary views of a shoe sole(fabric, etc.) 5200, 5300, 5400 that incorporates micro-levers 5210,5220, 4810, 4820, 5310, 5410, according to various embodiments of thepresent disclosure. Starting with FIG. 52, the micro-levers 5210, 5220are generally similar in design and function to the micro-levers 4810,4820 of FIG. 48, with some variations in the designs. More specifically,the micro-lever 5210 includes a bottom base 5212 that has its apexrotatably (or movably) connected to the apex of an inverted upper base5214, which itself is secured to a platform 5211. The micro-lever 5220is generally similar to the micro-lever 5210 with the exception that themicro-lever 5220 has its bottom base 5222 integrally formed with aninverter upper base 5224, which itself is secured to a platform 5221. Inother terms, while the bottom and upper bases 5212, 5214 of themicro-lever 5210 form a minimal contact surface (i.e., point or line) attheir apexes, the bottom and upper bases 5222, 5224 of the micro-lever5220 form a larger contact surface than their respective apexes, whilestill be able to bend or ply under the effect of a force.

FIG. 53 illustrates a combination of exemplary micro-levers 4810, 4820,5310 that work in conjunction with each other. The cross-hatching hasbeen partially removed for clarity of illustration. In this particularembodiment, and although the representative micro-levers 4810, 4820 areillustrated, it should be clear that other micro-levers embodiments maybe used, alternatively to, or in conjunction with the micro-levers 4810,4820. The three (or more) micro-levers 4810, 4820 are so formed in closeproximity to (or in contact with) each other, so that a force (e.g., F)applied to one micro-lever (e.g., 4810) may result in reactionary forces(e.g., R, H, Q) on at least some (or all) of the remaining micro-levers(e.g., 4820, 5310), resulting from the lever effect and the selectivedispersal, absorption, redirection of forces.

The micro-lever 5310 is illustrated to have a generally semi-circular(or semi-cylindrical), though other embodiments or designs may be usedinstead. While one of the objectives of the micro-levers 4810, 4820 isto redirect (e.g., change of direction) the direction of the appliedforce (e.g., F to R, and R to H), one of the goals of the micro-lever5310 is to translate the applied force and not necessarily to redirectits direction (e.g., H to Q). This design of the micro-levers may turnthe encompassing sole or material 5300 into a programmable memory device(or programmable fabric), by regulating and controlling the transmissionof the applied forces throughout the fabric or medium 5300.

FIG. 54 is a cross-sectional, fragmentary view of a medium 5400, such asa shoe sole, fabric, etc. that incorporates a dynamic micro-lever 5410according to one embodiment of the present disclosure. The micro-lever5410 is generally similar in function to the micro-levers describedearlier, with the difference being that the micro-lever 5410 is dynamic.

To this end, the micro-lever 5410 includes a bottom base 5412 that ismovable or slidable within a fluid medium 5414, and both the bottom base5412 and the fluid medium 5414 are encapsulated within a chamber definedby a platform 5411 that is generally similar in function and design tothe platform 4811 with the exception that the platform 5411 is longer(or wider) than the platform 4811, in order to allow a longer travelpath to the bottom base 5412. In addition, while the bottom base 4812 isdescribed as being secured to the platform 4811, the bottom base 5412 isnot secured to the platform 5411, but is rather allowed to traveltherealong, so as to change its lever action, that is to adjust thelength of the lever arm between the force F and the apex of the bottombase 5412.

More specifically, when the force F is applied on one end of theplatform 5411, it generates a force A that causes the bottom base 5412to translate in the direction of the force A. However, the force A iscountered with a resistance force L and is consequently reduced to forceB and then to force C, until the bottom base reaches a rest point andstops its travel, allowing the lever action to affect the movement ofthe other (or opposite) end of the platform 5411, thus accomplishingdynamicity and self-adjustment.

FIG. 55 is a top view of the medium 5400 of FIG. 54, showing theplacements of various static and dynamic micro-levers (in dotted lines)within the medium 5400, according to one embodiment of the presentdisclosure.

While the present micro-levers are illustrated and described for use invarious media, it should be clear that the present inventive concept maybe used in numerous other applications, including but not limited tomedical applications, such as sub-cutaneous implants, etc.

FIGS. 56, 57, 58, 59 illustrate shock absorbent mechanisms 5600, 5900that can be incorporated or formed within the medium 5400 of FIG. 55,according to one embodiment of the present disclosure. Starting at FIG.56, the mechanism 5600 generally includes a device or element thatgenerates an electrical current (voltage or power), such as apiezoelectric element 5610. The mechanism 5600 further includes asolenoid 5620 that is electrically connected to the piezoelectricelement 5610 by means of an electric cable (or a similar electricalconnector, such as a metallic trace) 5630.

Although in this exemplary embodiment the piezoelectric element 5610 isshown mounted atop the solenoid 5620, it should be understood thatalternative positions of the piezoelectric element 5610 relative to thesolenoid 5620 are envisioned by the present disclosure.

FIGS. 56, 57 illustrate the operation of the mechanism 5600 upon theapplication of a force F. As shown in FIG. 57, when a force F is appliedto the piezoelectric element 5610, the latter generates a correspondingelectrical current, I, that feeds the solenoid 5620. As furtherillustrated in FIG. 58, the solenoid 5620, which is generally formed ofa coil 5621 and a plunger 5622, is activated by the applied current, I,to generate a reactive force, R. The reactive force, R, forces theplunger 5622 to move upward (or in the direction countering the appliedforce, F). In some applications, the current, I, is amplified by anamplifier to generate a sufficient reactive force, R, so that theplunger head 5625 is raised above its resting position.

FIG. 59 illustrates an exemplary mechanical amplification device (oramplifier 5910. In one embodiment, the amplifier 5910 includes a levermechanism that is similar in concept and design to the lever mechanisms4310, 4320 of FIG. 43, as described in greater detail above, whichdescription is incorporated herein by this reference. In thisembodiment, if the piezoelectric element 5610 were to generate a force R(as is shown in FIGS. 56, 57, 58), the amplifier 5910 generates a force,nR, that is a multiple of the force, R, thus amplifying it. It should benoted that various control devices of the current, I, may beincorporated within the design of the embodiments of FIGS. 56 through59, which control devices may be physically embedded within the medium5400 alongside or proximity to the mechanism 5600, or alternatively,these control devices could be remotely incorporated within the postureadjustment mechanisms 4158, 4188 or the feedback device 4180 of FIG. 41.

FIGS. 60, 61, 62, 63, 64 illustrate alternative shock absorbent“pebbles” 6000 that can be incorporated or formed within medium 5400 ofFIG. 55, according to one embodiment of the present disclosure. Startingwith FIG. 60, the pebble 6000 is generally formed of a deformable(plastic or elastic) membrane 6010 that defines two chambers 6011 and6012 that are connected with an air permeable (or compressible gaspermeable) membrane 6015. The membrane 6015 is permeable to air (or gas)but not to water (liquid, fluid, or gel).

In a resting position, the first chamber 6011 is filled with a mixtureof air (or gas) 6016 along with water (liquid, fluid, or gel) 6018. Thesecond chamber 6012 is filled with the same (similar or dissimilar) gas6019 as the gas 6016. Both chambers 6011, 6012 remain at equilibriumuntil an external force is applied to the first chamber 6011 (FIG. 61)or to the second chamber 6012 (FIG. 63). In one embodiment, the gel 6018may be agrose gel.

With reference to FIG. 61, as the force F is applied to the firstchamber 6011, the fluid 6018 contained therewithin may not becompressed, but the gas 6016 may be compressed. As a result, at leastsome of the gas molecules are forced into the second chamber 6012,inflating it until such time as the force F is balanced (or equalized)by the gas pressure in the second chamber 6012, at which time the flowof the gas molecules 6016 from the first chamber 6011 to the secondchamber 6012 stops. In consequence, the force F is absorbed by theoperation of the pebble 6000 as described. The pebbles 6000 may bemicro-sized (as micro-capsules) for distribution over a large area, orsized according to the desired application. The pebbles 6000 may havevarious commercial applications as described herein, and furtherincluding but not limited to packaging of transported items or militaryarsenals.

FIGS. 62, 63 illustrate the pebble 6000 as described earlier inconnection with FIGS. 60, 61. However, in this embodiment, the pebble6000 is used in an inverted position, so that the force, F, is appliedto the second chamber 6012. This application may be desirable insituations where the pebbles 6000 are disbursed or formedindiscriminately. The operation of the pebble 6000 of FIGS. 62, 63 isgenerally similar to that of the pebble 6000 of FIGS. 60, 61, with thevariation that as the force F is applied to the second chamber 6012 andcause at least some of the molecules of the gas 6019 to traverse theintermediate membrane 6015 into the first chamber 6011, to counter orabsorb the force F, as described earlier.

FIGS. 64, 65, illustrate two additional embodiments of the pebbles 6400,6500, wherein the pebbles 6400, 6500 are formed of a membrane thatdefines more than just two chambers as described in connection withFIGS. 60 through 63. In the embodiment illustrated in FIG. 64, thepebble 6400 is formed of three chambers 6410, 6420, 6430. The upperchamber 6410 contains a gas, the intermediate chamber 6420 containseither a liquid or a combination of liquid/gas combination, and thebottom chamber 6430 contains gas. As a result, when force F is applied,the gas molecules in the upper chamber 6410 and the bottom chamber 6430are precipitated, through the gas permeable membranes 6440, 6450 to theintermediate chamber 6420, as described earlier.

In the embodiment illustrated in FIG. 64, the pebble 6400 is formed ofthree chambers 6410, 6420, 6430. The upper chamber 6410 contains a gas,the intermediate chamber 6420 contains either a liquid or a combinationof liquid and gas, and the bottom chamber 6430 contains gas. As aresult, when force F is applied, the gas molecules in the upper chamber6410 and the bottom chamber 6430 are precipitated, through the gaspermeable membranes 6440, 6450 to the intermediate chamber 6420, asdescribed earlier.

In the embodiment illustrated in FIG. 65, the pebble 6500 is formed ofthree chambers 6510, 6520, 6530. The upper chamber 6510 contains eithera liquid or a combination of liquid and gas, the intermediate chamber6520 contains a gas, and the bottom chamber 6530 contains either aliquid or a combination of liquid and gas. As a result, when force F isapplied, the gas molecules in the intermediate chamber 6520 areprecipitated, through the gas permeable membranes 6540, 6550 to theupper chamber 6510 and to the bottom chamber 6520, as described earlier.

It should be understood that various other combinations of chambers andgas or liquid contained therein, are contemplated by the presentdisclosure. In addition, while particular embodiments of the presentinvention have been disclosed, it is to be understood that variousdifferent modifications are possible and are contemplated within thescope of the specification, drawings, abstract and appended claims.

In each of the flow charts described herein, one or more of the methodsmay be embodied in a computer readable medium containing computerreadable code such that a series of steps are performed when thecomputer readable code is executed on a computing device. In someimplementations, certain steps of the methods are combined, performedsimultaneously or in a different order, or perhaps omitted, withoutdeviating from the spirit and scope of the invention. Thus, while themethod steps are described and illustrated in a particular sequence, theuse of a specific sequence of steps is not meant to imply anylimitations on the invention. Changes may be made with regards to thesequence of steps without departing from the spirit or scope of thepresent invention. The use of a particular sequence is therefore, not tobe taken in a limiting sense, and the scope of the present invention isdefined only by the appended claims.

As it will be appreciated by one skilled in the art, aspects of thepresent invention may be embodied as a system, method, or computerprogram product. Accordingly, aspects of the present invention may takethe form of an entirely hardware embodiment, an entirely softwareembodiment (including firmware, resident software, micro-code, etc.) oran embodiment combining software and hardware aspects that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, aspects of the present invention may take the form of acomputer program product embodied in one or more computer readablemedium(s) having computer readable program code embodied thereon.

As it will be further appreciated, the processes in embodiments of thepresent invention may be implemented using any combination of software,firmware or hardware. As a preparatory step to practicing the inventionin software, the programming code (whether software or firmware) willtypically be stored in one or more computer readable storage mediums forexample, but not limited to, an electronic, magnetic, optical,electromagnetic, infrared, or semiconductor system, apparatus, ordevice, or any suitable combination of the foregoing. More specificexamples (a non-exhaustive list) of the computer readable storage mediumwould include the following: an electrical connection having one or morewires, a portable computer diskette, a hard disk, a random-access memory(RAM), a read-only memory (ROM), an erasable programmable read-onlymemory (EPROM or Flash memory), a portable compact disc read-only memory(CD-ROM), an optical storage device, a magnetic storage device, or anysuitable combination of the foregoing. In the context of this document,a computer readable storage medium may be any tangible medium that cancontain, or store a program for use by or in connection with aninstruction execution system, apparatus, or device.

The article of manufacture containing the programming code is used byeither executing the code directly from the storage device, by copyingthe code from the storage device into another storage device such as ahard disk, RAM, etc., or by transmitting the code for remote executionusing transmission type media such as digital and analog communicationlinks. The methods of the invention may be practiced by combining one ormore machine-readable storage devices containing the code according tothe present invention with appropriate processing hardware to executethe code contained therein. An apparatus for practicing the inventioncould be one or more processing devices and storage systems containingor having network access to program(s) coded in accordance with theinvention.

A computer readable signal medium may include a propagated data signalwith computer readable program code embodied therein, for example, inbaseband or as part of a carrier wave. Such a propagated signal may takeany of a variety of forms, including, but not limited to,electro-magnetic, optical, or any suitable combination thereof. Acomputer readable signal medium may be any computer readable medium thatis not a computer readable storage medium and that can communicate,propagate, or transport a program for use by or in connection with aninstruction execution system, apparatus, or device.

Program code embodied on a computer readable medium may be transmittedusing any appropriate medium, including but not limited to wireless,wireline, optical fiber cable, R.F, etc., or any suitable combination ofthe foregoing. Computer program code for carrying out operations foraspects of the present invention may be written in any combination ofone or more programming languages, including an object-orientedprogramming language such as Java, Smalltalk, C++ or the like andconventional procedural programming languages, such as the “C”programming language or similar programming languages. The program codemay execute entirely on the user's computer, partly on the user'scomputer, as a stand-alone software package, partly on the user'scomputer and partly on a remote computer or entirely on the remotecomputer or server. In the latter scenario, the remote computer may beconnected to the user's computer through any type of network, includinga local area network (LAN) or a wide area network (WAN), or theconnection may be made to an external computer (for example, through theInternet using an Internet Service Provider).

Thus, it is important that while illustrative embodiments of the presentinvention are described in the context of a fully functional computer(server) system with installed (or executed) software, those skilled inthe art will appreciate that the software aspects of the illustrativeembodiments of the present invention are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the present invention applies equally regardless of theparticular type of media used to actually carry out the distribution.

In addition, while the present invention has been described withreference to exemplary embodiments, it will be understood by thoseskilled in the art that various changes may be made and equivalents maybe substituted for elements thereof without departing from the scope ofthe invention. Furthermore, many modifications may be made to adapt aparticular system, device or component thereof to the teachings of theinvention without departing from the essential scope thereof. Therefore,it is intended that the invention not be limited to the particularembodiments disclosed for carrying out this invention, but that theinvention will include all embodiments falling within the scope of theappended claims.

As used herein, the singular forms “a”, “an”, and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof. Moreover, the use of the terms first,second, etc. do not denote any order or importance, but rather the termsfirst, second, etc. are used to distinguish one element from another. Inaddition, listing terms such as “a”, “b”, c”, “first”, “second”, and“third” are used herein and in the appended claims for purposes ofdescription and are not intended to indicate or imply relativeimportance or significance.

The corresponding structures, materials, acts, and equivalents of allmeans or step plus function elements in the claims below are intended toinclude any structure, material, or act for performing the function incombination with other claimed elements as specifically claimed. Thedescription of the present invention has been presented for purposes ofillustration and description, but is not intended to be exhaustive orlimited to the invention in the form disclosed. Many modifications andvariations will be apparent to those of ordinary skill in the artwithout departing from the scope and spirit of the invention. Theembodiment was chosen and described in order to best explain theprinciples of the invention and the practical application, and to enableothers of ordinary skill in the art to understand the invention forvarious embodiments with various modifications as are suited to theparticular use contemplated.

What is claimed is:
 1. A programmable medium for distributing at leastpart of a force or shock, F, applied onto the medium, the mediumcomprising: a programmable combination of levers that are selectivelydistributed within the medium to allow at least some of the levers tocooperate in order to selectively disperse, absorb, redirect, ortranslate at least part of the force or shock, F, in a customizablefashion; wherein the medium includes a pliable material thatencapsulates at least part of said some of the levers; wherein said someof the levers are formed of a material that is stiffer than the pliablematerial of the medium, so that as the force or shock, F, is appliedonto said some of the levers, said some of the levers enable a leveraction or momentum by pivoting within the pliable material; wherein thepliable material is deformable, plastic, or elastic; wherein said someof the levers include at least a first lever and a second lever; andwherein the first lever and the second lever are disposed in closeproximity relative to each other so that as at least part of the forceor shock, F, is applied at least in part onto the first lever, the firstlever pivots within the pliable material to engage the second lever, soas and to apply a reactionary force, R, to the second lever, effectivelydispersing, absorbing, redirecting, or translating said at least part ofthe force or shock, F, within the medium, for regulating thedistribution of said at least part of the force or shock, F, within themedium.
 2. The programmable medium of claim 1, wherein the first leverincludes a first platform that is pivotally secured to a first apex;wherein the second lever includes a second platform that is pivotallysecured to a second apex; wherein as at least part of the force orshock, F, is applied at least in part on the first lever, the firstplatform pivots around the first apex and causes said at least part ofthe force or shock, F, to be reoriented by the first lever so that thefirst platform applies the reactionary force, R, to the second platform;and wherein the second lever reorients the reactionary force, R, into aforce, H, effectively spatially distributing the force or shock, F,through the medium.
 3. The programmable medium of claim 2, wherein saidsome of the levers further include a third lever that extends from thesecond platform and that further translates at least part of the force,H, through the medium.
 4. The programmable medium of claim 3, whereinthe third lever is semi-circularly shaped.
 5. The programmable medium ofclaim 1, wherein the first lever pivots within the pliable material topush against the second lever and to apply the reactionary force, R,onto the second lever.
 6. The programmable medium of claim 1, whereinthe pliable material is made of a synthetic resin, and wherein the firstlever and the second lever are made at least in part of hard plastic orrubber.
 7. The programmable medium of claim 1, wherein the medium ispart of any of: a shoe sole, a fabric, or packaging material.
 8. Theprogrammable medium of claim 1, wherein the programmable combination oflevers includes a plurality of programmably interacting micro-leversthat are distributed through the medium.
 9. A programmable medium fordistributing at least part of a force or shock, F, applied onto themedium, the medium comprising: a programmable combination of levers thatare selectively distributed within the medium to allow at least some ofthe levers to cooperate in order to selectively disperse, absorb,redirect, or translate at least part of the force or shock, F, in acustomizable fashion; wherein the medium includes a pliable materialthat encapsulates at least part of said some of the levers; wherein saidsome of the levers are formed of a material that is stiffer relative tothe pliable material of the medium, so that as said at least part of theforce or shock, F, is applied onto said some of the levers, said some ofthe levers enable a lever action or momentum by pivoting within thepliable material; wherein said at least some of the levers include atleast a first lever and a second lever; wherein the first lever includesa first platform that is pivotally secured to a first apex; and whereinthe first platform includes a first free end and a second free end thatare disposed on opposite sides relative to the first apex, so that assaid at least part of the force or shock, F, is applied onto the firstfree end of the first platform, the lever action or momentum causes thesecond free end of the first platform to pivot around the first apex andto apply a reactionary force or shock, R, to the second lever,effectively dispersing, absorbing, redirecting, or translating said atleast part of the force or shock, F, within the medium, for regulatingthe distribution of said at least part of the force or shock, F, withinthe medium.
 10. The programmable medium of claim 9, wherein the secondlever includes a second platform that is pivotally secured to a secondapex; wherein the second platform includes a third free end and a fourthfree end that are disposed on opposite sides relative to the secondapex; and wherein the reactionary force or shock, R, is applied at leastin part on the third free end of the second platform, causing the thirdfree end and the fourth free end to pivot around the second apex. 11.The programmable medium of claim 10, wherein as said at least part ofthe reactionary force or shock, R, is applied onto the third free end ofthe second platform, the lever action or momentum generates a reorientedreactionary force or shock, H, onto the fourth free end of the secondlever, effectively further dispersing, absorbing, redirecting, ortranslating said at least part of the force or shock, F, within themedium, for further regulating the distribution of said at least part ofthe force or shock, F, within the medium.
 12. The programmable mediummemory device of claim 9, wherein the programmable combination of leversincludes a plurality of micro-levers that are distributed through themedium.
 13. The programmable medium of claim 12, wherein the pluralityof micro-levers include a dynamic micro-lever.
 14. The programmablemedium of claim 13, wherein the medium includes a fluid medium; whereinthe dynamic micro-lever includes a bottom base that is movable orslidable within the fluid medium; and wherein the bottom base and thefluid medium are encapsulated within a chamber defined by a movableplatform.
 15. The programmable medium of claim 14, wherein the bottombase is allowed to travel along the platform so as to change the leveraction or momentum of the dynamic micro-lever by dynamically adjustingthe length of a lever arm of the platform, between the force or shock,F, and the top portion of the bottom base.
 16. The programmable mediumof claim 12, further including a heat source that is connected to saidat least one of the micro-levers.
 17. The programmable medium of claim12, further including a base that provides a common support to at leastsome of the plurality of micro-levers.
 18. The programmable medium ofclaim 17, wherein the base is formed of rubber or hard plastic.
 19. Theprogrammable medium of claim 17, wherein said at least some of theplurality of micro-levers are affixed to the base.
 20. The programmablemedium of claim 17, wherein said at least some of the plurality ofmicro-levers are slidably supported by the base.